Chrysalis Intelligence · Sponsors · Abbott Laboratories

Abbott Laboratories

Abbott Park, IL, US · 16 510(k) clearances · 156 PMAs · 33 recalls

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Total clearances
16
2021-01-08 → 2026-04-28
Last 12 months
1
Product codes
11
Most recent
2026-04-28
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QAT Brain Trauma Assessment Test Class II Immunology 3 2023-09-29
GKZ — — — 2 2025-02-20
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Class II Microbiology 2 2024-08-30
DHA System, Test, Human Chorionic Gonadotropin Class II Clinical Chemistry 2 2023-06-05
MZO — — — 1 2026-04-28
LCD — — — 1 2025-07-09
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Class II Microbiology 1 2025-06-20
LOL Hepatitis A Test (Antibody And Igm Antibody) Class II Microbiology 1 2023-08-10
GJS Test, Time, Prothrombin Class II Hematology 1 2023-07-14
LFZ — — — 1 2022-10-27
JGS Electrode, Ion Specific, Sodium Class II Clinical Chemistry 1 2022-03-10
Class III

PMA approvals (156)

Total PMA records
156
Originals + supplements
Distinct product codes
6
First decision
2020-01-07
Most recent
2026-05-11
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-05-11 P120008-S032 ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) 30-Day Notice LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2026-02-23 P910007-S068 ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92) 30-Day Notice MTF — —
2026-02-12 P980007-S056 ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) 30-Day Notice MTG — —
2026-02-12 P910007-S067 ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92) 30-Day Notice MTF — —
2026-02-12 P120008-S031 ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) 30-Day Notice LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2025-04-03 P980007-S055 ARCHITECT Free PSA / Alinity i Free PSA 30-Day Notice MTG — —
2025-04-03 P910007-S066 ARCHITECT Total PSA / Alinity i Total PSA 30-Day Notice MTF — —
2025-04-03 P210003-S013 ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-03 P120008-S030 ARCHITECT AFP / Alinity i AFP 30-Day Notice LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2025-04-03 P110029-S052 ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-03 P080023-S046 ARCHITECT CORE / Alinity i Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-03 P060035-S043 ARCHITECT CORE-M / Alinity i Anti-HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-03 P050051-S061 ARCHITECT AUSAB; Alinity i Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-09-30 P210003-S012 ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-09-30 P110029-S051 ARCHITECT HBsAg Qualitative/Confirmatory, Alinity i HBsAg Qualitative II/ Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-05-23 P110029-S050 ARCHITECT HBsAg Qualitative Confirmatory/ Alinity i HBsAg Qualitative II Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-05-23 P050051-S060 ARCHITECT AUSAB/Alinity i Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-03-22 P210003-S011 ARCHITECT HBsAg Next Qualitative I Qualitative Confirmatory/ Alinity i HBsAg Next Qualitative I Alinity i HBsAg Next Con 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-03-22 P120008-S029 ARCHITECT AFP / Alinity i AFP 30-Day Notice LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2024-03-22 P080023-S045 ARCHITECT CORE/ Alinity i Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-03-22 P050051-S059 ARCHITECT AUSAB / Alinity i Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-01-30 P120008-S028 Architect AFP and Alinity i AFP 30-Day Notice LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2024-01-19 P050051-S050 ARCHITECT AUSAB Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-12-14 P980007-S054 ARCHITECT Free PSA / Alinity i Free PSA 30-Day Notice MTG — —
2023-12-14 P910007-S065 ARCHITECT Total PSA / Alinity i Total PSA 30-Day Notice MTF — —
2023-12-14 P210003-S010 ARCHITECT HBsAg Next Qualitative / Alinity i HBsAg Next Qualitative, ARCHITECT HBsAg NEXT Confirmatory / Alinity i HBsAg 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-12-14 P120008-S027 ARCHITECT AFP / Alinity i AFP 30-Day Notice LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2023-12-14 P110029-S049 ARCHITECT HBsAg Qualitative / Alinity i HBsAg Qualitative II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-12-14 P080023-S044 ARCHITECT CORE / Alinity i Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-12-14 P060035-S042 ARCHITECT CORE-M / Alinity i Anti-HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-12-14 P050051-S058 ARCHITECT AUSAB / Alinity i Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-12-07 P210003-S009 ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-12-07 P110029-S048 ARCHITECT HBsAg Qualitative/Confirmatory, Alinity i HBsAg Qualitative II/Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-12-07 P050051-S057 ARCHITECT AUSAB, Alinity i Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-11-08 P980007-S053 Alinity i Free PSA Reagent Kit Real-Time Process MTG — —
2023-11-08 P910007-S064 Alinity i Total PSA Reagent Kit Real-Time Process MTF — —
2023-11-08 P120008-S026 Alinity i AFP Reagent Kit Real-Time Process LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2023-11-06 P110029-S047 Alinity i HBsAg Qualitative II Reagent Kit (2x l 00 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Al Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-11-06 P080023-S043 Alinity i Anti-HBc Reagent Kit (2x 100 Tests), Alinity i Anti-HBc Reagent Kit (2x600 Tests) Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-11-06 P060035-S041 Alinity i Anti-HBc IgM Reagent Kit (2xl00 Tests) Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-11-06 P050051-S056 Alinity i Anti-HBs Reagent Kit (2x 100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-11-03 P110029-S046 Alinity i HBsAg Qualitative II Reagent Kit (2x100 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Alin Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-11-03 P080023-S042 Alinity i Anti-HBc Reagent Kit (2x100 Tests), Alinity i Anti-HBc Reagent Kit (2x600 Tests) Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-11-03 P060035-S040 Alinity i Anti-HBc IgM Reagent Kit (2x100 Tests) Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-11-03 P050051-S055 Alinity i Anti-HBs Reagent Kit (2x100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent K Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-10-11 P980007-S049 ARCHITECT Free PSA, Alinity i Free PSA Normal 180 Day Track MTF — —
2023-10-11 P910007-S060 ARCHITECT Total PSA, Alinity i Total PSA Normal 180 Day Track MTF — —
2023-10-11 P210003-S007 ARCHITECT HBsAg Next Qualitative / Next Confirmatory Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-10-11 P120008-S022 ARCHITECT AFP, Alinity i AFP Normal 180 Day Track LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2023-10-11 P110029-S042 ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf Normal 180 Day Track — — —
2023-10-11 P080023-S040 ARCHITECT CORE / Alinity i Anti-HBc Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-10-11 P060035-S038 ARCHITECT CORE-M / Alinity i Anti-HBc IgM Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-10-11 P050051-S051 ARCHITECT AUSAB / Alinity i Anti-HBs Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-09-28 P210003-S006 Alinity i HBsAg Next Qualitative assay, Alinity i HBsAg Next Confirmatory assay Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-09-25 P980007-S052 Alinity i Free PSA Real-Time Process MTG — —
2023-09-25 P910007-S063 Alinity i Total PSA Real-Time Process MTF — —
2023-09-25 P120008-S025 Alinity i AFP Real-Time Process LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2023-07-10 P980007-S051 ARCHITECT Free PSA / Alinity i Free PSA 30-Day Notice MTG — —
2023-07-10 P910007-S062 ARCHITECT Total PSA / Alinity i Total PSA 30-Day Notice MTF — —
2023-07-10 P210003-S008 ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-07-10 P120008-S024 ARCHITECT AFP / Alinity i AFP 30-Day Notice LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2023-07-10 P110029-S045 ARCHITECT HBsAg Qualitative/ Qualitative Confirmatory / Alinity i HBsAg Qualitative II/ Qualitative II Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-07-10 P080023-S041 ARCHITECT CORE / Alinity i Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-07-10 P060035-S039 ARCHITECT CORE-M / Alinity i Anti-HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-07-10 P050051-S054 ARCHITECT AUSAB / Alinity i Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-06-23 P110029-S043 ARCHITECT HBsAg Qualitative/HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative/HBsAg Qualitative Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-06-22 P980007-S050 ARCHITECT Free PSA, Alinity i Free PSA 30-Day Notice MTG — —
2023-06-22 P910007-S061 ARCHITECT Total PSA, Alinity i Total PSA 30-Day Notice MTF — —
2023-06-22 P120008-S023 ARCHITECT AFP, Alinity i AFP 30-Day Notice LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2023-06-22 P110029-S044 ARCHITECT HBsAg Qualitative, HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II/Qualitative II Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-06-22 P050051-S052 ARCHITECT AUSAB, Alinity i Anti-HBs 30-Day Notice — — —
2023-05-08 P210003-S004 ARCHITECT HBsAg Next Qualitative and ARCHITECT HBsAg Next Confirmatory Assay Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-01-30 P980007-S048 ARCHITECT Free PSA / Alinity i Free PSA 30-Day Notice — — —
2023-01-30 P910007-S059 ARCHITECT Total PSA / Alinity i Total PSA 30-Day Notice — — —
2023-01-30 P210003-S005 ARCHITECT HBsAg Next Qualitative / Next Confirmatory 30-Day Notice — — —
2023-01-30 P120008-S021 ARCHITECT AFP / Alinity i AFP 30-Day Notice LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2023-01-30 P110029-S041 ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf 30-Day Notice — — —
2023-01-30 P080023-S039 ARCHITECT CORE / Alinity i Anti-HBc 30-Day Notice — — —
2023-01-30 P060035-S037 ARCHITECT CORE-M / Alinity i Anti-HBc IgM 30-Day Notice — — —
2023-01-30 P050051-S049 ARCHITECT AUSAB / Alinity i Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-12-07 P210003-S003 ARCHITECT HBsAg Next Qualitative/Next Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-12-07 P110029-S040 ARCHITECT HBsAg Qualitative/Confirmatory/Alinity HBsAg Qualitative II/Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-12-07 P050051-S048 ARCHITECT AUSAB/Alinity i Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-10-25 P080023-S038 Alinity i Anti-HBc (List Number 07P84) 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-10-25 P060035-S036 Alinity i Anti-HBc IgM (List Number 07P86) 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-10-12 P980007-S047 ARCHITECT Free PSA / Alinity i Free PSA 30-Day Notice MTG — —
2022-10-12 P910007-S058 ARCHITECT Total PSA / Alinity i Total PSA 30-Day Notice MTF — —
2022-10-12 P210003-S002 ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-10-12 P120008-S020 ARCHITECT AFP / Alinity i AFP 30-Day Notice LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2022-10-12 P110029-S039 ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-10-12 P080023-S037 ARCHITECT CORE / Alinity i Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-10-12 P060035-S035 ARCHITECT CORE-M / Alinity i Anti-HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-10-12 P050051-S047 ARCHITECT AUSAB / Alinity i Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-09-30 P210003-S001 ARCHITECT HBsAg Next Qualitative/ Next Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-09-30 P110029-S038 ARCHITECT HBsAg Qualitative/Confirmatory/Alinity i HBsAg Qualitative II/Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-09-30 P050051-S046 ARCHITECT AUSAB / Alinity i Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-08-10 P210003 ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit Original LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-08-10 P110029-S037 ARCHITECT HBsAg Qualitative/Qualitative Confirmatory, Alinity i HBsAg Qualitative II/Qualitative II Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-04-14 P050051-S043 ARCHITECT AUSAB, Alinity i Anti-HBs Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-17 P120008-S019 ARCHITECT AFP / Alinity i AFP 30-Day Notice LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2021-12-15 P980007-S046 ARCHITECT Free PSA / Alinity i Free PSA 30-Day Notice MTG — —
2021-12-15 P910007-S057 ARCHITECT Total PSA / Alinity i Total PSA 30-Day Notice MTF — —
2021-12-15 P110029-S036 ARCHITECT HBsAg Qualitative/Confirmatory / Alinity i HBsAg Qualitative II/Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-15 P080023-S036 ARCHITECT CORE / Alinity i Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-15 P060035-S034 ARCHITECT CORE-M / Alinity i Anti-HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-15 P050051-S045 ARCHITECT AUSAB / Alinity i Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-15 P050042-S047 ARCHITECT Anti-HCV / Alinity i Anti-HCV 30-Day Notice MZO — —
2021-12-06 P980007-S045 ARCHITECT Free PSA (LN 6C07) 30-Day Notice MTG — —
2021-12-06 P910007-S056 ARCHITECT Total PSA (LN 6C06) 30-Day Notice MTF — —
2021-12-06 P120008-S018 ARCHITECT AFP (LN 3P36) 30-Day Notice LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2021-12-06 P110029-S035 ARCHITECT HBsAg Qualitative (LN 4P53), ARCHITECT HBsAg Qualitative Confirmatory (LN 4P54) 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-06 P080023-S035 ARCHITECT CORE (LN 6L22) 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-06 P060035-S033 ARCHITECT CORE-M (LN 6L23) 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-06 P050051-S044 ARCHITECT AUSAB (LN 1L82) 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-06 P050042-S046 ARCHITECT Anti-HCV (LN 1L79) 30-Day Notice MZO — —
2021-09-09 P050051-S042 Abbott ARCHITECT AUSAB Reagent (100 Test), Abbott ARCHITECT AUSAB Reagent (500 Test), Abbott ARCHITECT AUSAB Reagent, Al 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-05-14 P060035-S031 ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit 135 Review Track For 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-04-22 P980007-S044 ARCHITECT Free PSA Reagent Kit, Alinity i Free PSA Reagent Kit Real-Time Process MTG — —
2021-04-22 P910007-S055 ARCHITECT Total PSA Reagent Kit, Alinity i Total PSA Reagent Kit Real-Time Process MTF — —
2021-04-22 P120008-S017 ARCHITECT AFP Reagents, Alinity i AFP Reagent Kit Real-Time Process LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2021-04-22 P110029-S034 ARCHITECT HBsAg Qualitative Reagent, ARCHITECT HBsAg Qualitative Confirmatory Reagent, Alinity i HBsAg Qualitative II Re Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-04-22 P080023-S034 ARCHITECT CORE Reagent Kit, Alinity i Anti-HBc Reagent Kit Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-04-22 P060035-S032 ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-04-22 P050051-S041 ARCHITECT AUSAB Reagent, ARCHITECT AUSAB Reagent Kit, Alinity i Anti-HBs Reagent Kit Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-04-22 P050042-S045 ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV Reagent Kit Real-Time Process MZO — —
2020-11-05 P980007-S043 ARCHITECT Free PSA and Alinity i Free PSA 30-Day Notice MTG — —
2020-11-05 P910007-S054 ARCHITECT Total PSA and Alinity i Total PSA 30-Day Notice MTF — —
2020-11-05 P120008-S016 ARCHITECT AFP and Alinity i AFP 30-Day Notice LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2020-11-05 P050051-S040 ARCHITECT AUSAB and Alinity i Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-08-28 P050042-S044 ARCHITECT Anti-HCV, Alinity i Anti-HCV 30-Day Notice MZO — —
2020-08-07 P910007-S051 Alinity i Total PSA Assay Normal 180 Day Track MTF — —
2020-07-30 P110029-S033 ARCHITECT HBsAg Qualitative Reagent Kit, ARCHITECT HBsAg Qualitative Reagent Kit, ARCHITECT HBsAg Qualitative Confirmato 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-06-05 P980007-S041 Alinity i Free PSA assay Normal 180 Day Track MTG — —
2020-06-05 P120008-S013 Alinity i AFP Reagent Kit Real-Time Process LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2020-06-05 P110029-S030 Alinity i HBsAg Qualitative II Reagent Kit and Alinity i HBsAg Qualitative II Confirmatory Kit Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-06-05 P080023-S031 Alinity i Anti-HBc Reagent Kit Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-06-05 P060035-S028 Alinity i Anti-HBc IgM Reagent Kit Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-06-05 P050051-S037 Alinity i Anti-HBs Reagent Kit Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-06-05 P050042-S040 Alinity i Anti-HCV Reagent Kit Real-Time Process MZO — —
2020-05-23 P980007-S042 ARCHITECT Free PSA Normal 180 Day Track No User Fee MTG — —
2020-05-23 P910007-S053 ARCHITECT Total PSA Normal 180 Day Track No User Fee MTF — —
2020-05-23 P120008-S015 ARCHITECT AFP Normal 180 Day Track No User Fee LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2020-05-23 P120008-S014 Alinity i AFP Normal 180 Day Track No User Fee LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown
2020-05-23 P110029-S032 ARCHITECT HBsAg Qualitative/Confirmatory Normal 180 Day Track No User Fee LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-05-23 P110029-S031 Alinity i HBsAg Qualitative II Normal 180 Day Track No User Fee LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-05-23 P080023-S033 ARCHITECT CORE Normal 180 Day Track No User Fee LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-05-23 P080023-S032 Alinity i Anti-HBc Normal 180 Day Track No User Fee LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-05-23 P060035-S030 ARCHITECT CORE-M Normal 180 Day Track No User Fee LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-05-23 P060035-S029 Alinity i Anti-HBc lgM Normal 180 Day Track No User Fee LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-05-23 P050051-S039 ARCHITECT AUSAB Normal 180 Day Track No User Fee LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-05-23 P050051-S038 Alinity i Anti-HBs Normal 180 Day Track No User Fee LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-05-23 P050042-S042 ARCHITECT Anti-HCV Normal 180 Day Track No User Fee MZO — —
2020-05-23 P050042-S041 Alinity i Anti-HCV Normal 180 Day Track No User Fee MZO — —
2020-04-29 P050042-S043 ARCHITECT Anti-HCV and Alinity i Anti-HCV 30-Day Notice MZO — —
2020-04-10 P910007-S052 ARCHITECT Total PSA Reagent/Calibrator/Control Kit Real-Time Process MTF — —
2020-01-07 P110029-S029 Alinity i HBsAg Qualitative II, Alinity i HBsAg Qualitative Confirmatory Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
Safety

Recalls (33)

Class I (serious)
0
Risk of injury / death
Total recalls
33
Currently ongoing
29
Most recent
2025-11-13
DateSeverityStatusRecall # ProductCodeReason
2025-11-13 Class II Ongoing Z-0961-2026 Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 — Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is pot…
2025-09-18 Class II Ongoing Z-0489-2026 Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.… — Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect r…
2025-03-18 Class II Ongoing Z-1656-2025 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software v… — When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expir…
2025-03-18 Class II Ongoing Z-1655-2025 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software v… — When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expir…
2025-03-18 Class II Ongoing Z-1654-2025 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software v… — When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expir…
2025-03-18 Class II Ongoing Z-1653-2025 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software v… — When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expir…
2025-03-18 Class II Ongoing Z-1652-2025 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software v… — When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expir…
2024-06-14 Class II Ongoing Z-2681-2024 Alinity hq Analyzer, REF: 09P68-01 — 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then…
2024-02-21 Class II Ongoing Z-1476-2024 ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. — The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may…
2023-10-19 Class II Ongoing Z-0682-2024 ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 … — The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
2023-10-19 Class II Ongoing Z-0681-2024 Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer al… — The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
2023-10-19 Class II Ongoing Z-0680-2024 Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer … — The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
2023-10-19 Class II Ongoing Z-0604-2024 Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number … — The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
2023-05-30 Class II Ongoing Z-0613-2024 Alinity ci-series System Control Module, REF: 03R70-01 — There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during dail…
2022-11-24 Class III Ongoing Z-0958-2023 Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels — Reaction vessels may contain a potential contaminant that could affect their optical performance.
2022-07-26 Class II Ongoing Z-1660-2022 ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 — One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
2022-06-09 Class II Ongoing Z-1456-2022 REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL — There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
2022-06-09 Class II Ongoing Z-1455-2022 REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL — There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
2022-06-09 Class II Ongoing Z-1454-2022 REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL — There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
2022-03-08 Class II Ongoing Z-0891-2022 ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of… — This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the sp…
2022-02-03 Class II Ongoing Z-0749-2022 Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intende… — Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the e…
2021-09-29 Class II Ongoing Z-0272-2022 ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-0… — Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, los…
2021-09-29 Class II Ongoing Z-0271-2022 ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and… — Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, los…
2021-07-26 Class II Ongoing Z-2472-2021 Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model … — Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their…
2021-07-12 Class II Ongoing Z-2276-2021 Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening,… — A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
2021-06-10 Class II Ongoing Z-2187-2021 REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866 — There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for …
2021-06-10 Class II Ongoing Z-2186-2021 REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866 — There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for …
2021-06-10 Class II Ongoing Z-2185-2021 REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859 — There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for …
2021-06-10 Class II Ongoing Z-2184-2021 REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransfe… — There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a…
2020-04-02 Class II Terminated Z-2251-2020 Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system d… — In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Module hydraulic circuit may be dispensed into the Primary Tube l…
2020-04-01 Class III Terminated Z-1895-2020 ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal … — Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a …
2020-04-01 Class III Terminated Z-1894-2020 ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal … — Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a …
2020-04-01 Class III Terminated Z-1893-2020 ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal ins… — Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a …
Filings

All 510(k) clearances (16)

Date K-number Device Code Class Specialty
2026-04-28 K252424 Anti-HCV Next MZO — —
2025-07-09 K243500 ARCHITECT iGentamicin LCD — —
2025-06-20 K243168 Alinity i Rubella IgG LFX Class II Microbiology
2025-02-20 K243283 Alinity h-series System GKZ — —
2024-08-30 K233932 Alinity i Toxo IgM LGD Class II Microbiology
2023-09-29 K232669 TBI QAT Class II Immunology
2023-08-10 K222850 HAVAb IgG II LOL Class II Microbiology
2023-08-04 K220031 Alinity h-series System GKZ — —
2023-07-14 K220282 i-STAT PTplus Cartridge with the i-STAT 1 System GJS Class II Hematology
2023-06-05 K230937 Alinity i Total ß-hCG Reagent Kit, GLP systems Track DHA Class II Clinical Chemistry
2023-05-19 K230790 Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series DHA Class II Clinical Chemistry
2023-03-02 K223602 Traumatic brain injury (TBI) test QAT Class II Immunology
2022-10-27 K220949 Architect CMV IgG LFZ — —
2022-05-19 K210596 ARCHITECT Toxo IgG LGD Class II Microbiology
2022-03-10 K213486 GLP systems Track JGS Class II Clinical Chemistry
2021-01-08 K201778 i-STAT TBI Plasma cartridge with the i-STAT Alinity System QAT Class II Immunology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence