Chrysalis Intelligence · Sponsors · Abbott Molecular, Inc.

Abbott Molecular, Inc.

Des Plaines, IL, US · 11 510(k) clearances · 101 PMAs · 30 recalls (5 Class I)

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Total clearances
11
2022-04-29 → 2025-09-25
Last 12 months
1
Product codes
9
Most recent
2025-09-25
Name variants in FDA filings: Abbott Molecular / Abbott Molecular, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna Class II Microbiology 2 2025-07-28
QEP — — — 2 2023-03-03
MZP — — — 1 2025-09-25
PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Class II Microbiology 1 2025-07-01
QMI Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna Class II Microbiology 1 2025-03-24
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents Class II Microbiology 1 2025-02-14
QYA — — — 1 2025-01-30
QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test Class II Microbiology 1 2024-12-06
PGI — — — 1 2024-05-03
Class III

PMA approvals (101)

Total PMA records
101
Originals + supplements
Distinct product codes
11
First decision
2020-03-23
Most recent
2026-07-23
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-23 P230003-S015 Alinity m HR HPV Normal 180 Day Track No User Fee MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2026-06-22 P230003-S018 Alinity m HR HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2026-06-08 P230003-S014 Alinity m HR HPV Assay Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2026-05-28 P230003-S017 Alinity m HR HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2026-05-28 P170041-S009 Abbott RealTime IDH1 30-Day Notice OWD — —
2026-05-28 P170005-S006 Abbott RealTime IDH2 30-Day Notice OWD — —
2026-05-19 P230003-S016 Alinity m HR HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2026-05-15 P230003-S013 Alinity m HR HPV Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2026-03-20 P170041-S008 Abbott RealTime IDH1 30-Day Notice OWD — —
2026-03-20 P170005-S005 Abbott RealTime IDH2 30-Day Notice OWD — —
2026-03-12 P230003-S011 Alinity m HR HPV Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2026-02-24 P230003-S012 Alinity m HR HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2026-02-18 P150041-S008 Vysis CLL FISH Probe Kit 30-Day Notice PNK — —
2026-02-18 P110012-S023 Vysis ALK Break Apart FISH Probe Kit 30-Day Notice OWE — —
2026-02-18 P030052-S030 UroVysion Bladder Cancer Kit 30-Day Notice — — —
2026-01-06 P230003-S010 Alinity m HR HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2025-10-17 P230003-S009 Alinity m HR HPV Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2025-10-17 P200013-S027 Alinity m HBV Real-Time Process MKT Hepatitis Viral B Dna Detection Microbiology
2025-09-24 P230003-S008 Alinity m HR HPV Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2025-09-24 P200013-S026 Alinity m HBV Real-Time Process MKT Hepatitis Viral B Dna Detection Microbiology
2025-09-10 P230003-S006 Alinity m HR HPV Panel Track MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2025-08-08 P150041-S007 Vysis CLL Fish Probe Kit 30-Day Notice PNK — —
2025-08-05 P110012-S022 Vysis ALK Break Apart FISH Probe Kit Normal 180 Day Track OWE — —
2025-04-18 P230003-S007 Alinity m HR HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2025-04-18 P200013-S025 Alinity m HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2025-04-18 P080026-S026 Abbott RealTime HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2025-04-11 P200013-S024 Alinity m HBV Assay 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2025-04-11 P080026-S025 Abbott RealTime HBV Assay 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2025-01-29 P030052-S029 UroVysion Bladder Cancer Kit 30-Day Notice — — —
2024-12-23 P200013-S023 Alinity m HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2024-09-13 P230003-S004 Alinity m HR HPV Assay Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-09-13 P210022-S012 Alinity m CMV Assay Real-Time Process PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2024-09-13 P200013-S021 Alinity m HBV Assay Real-Time Process MKT Hepatitis Viral B Dna Detection Microbiology
2024-09-05 P230003-S005 Alinity m HR HPV Assay Special (Immediate Track) MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-09-05 P210022-S013 Alinity m CMV Assay Special (Immediate Track) PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2024-09-05 P200013-S022 Alinity m HBV Assay Special (Immediate Track) MKT Hepatitis Viral B Dna Detection Microbiology
2024-07-10 P230003-S003 Alinity m HR HPV Assay 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-07-10 P210022-S011 Alinity m CMV Assay 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2024-07-10 P200013-S020 Alinity m HBV Assay 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2024-02-05 P230003-S001 Alinity m HR HPV Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-02-05 P210022-S009 Alinity m CMV Real-Time Process PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2024-02-05 P200013-S018 Alinity m HBV Real-Time Process MKT Hepatitis Viral B Dna Detection Microbiology
2024-01-20 P230003-S002 Alinity m HR HPV Assay 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-01-20 P210022-S010 Alinity m CMV Assay 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2024-01-20 P200013-S019 Alinity m HBV Assay 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2024-01-16 P210022-S008 Alinity m CMV Real-Time Process PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2023-11-01 P230003 Alinity m HR HPV Original MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-10-24 P170041-S007 Abbott RealTime IDH1 Normal 180 Day Track OWD — —
2023-09-14 P210022-S007 Alinity m CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2023-09-14 P200013-S017 Alinity m HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2023-07-18 P200013-S015 Alinity m HBV Real-Time Process MKT Hepatitis Viral B Dna Detection Microbiology
2023-06-16 P210022-S005 Alinity m CMV Assay Real-Time Process PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2023-06-16 P200013-S014 Alinity m HBV Assay Real-Time Process MKT Hepatitis Viral B Dna Detection Microbiology
2023-03-31 P210022-S004 Alinity m CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2023-03-31 P200013-S013 Alinity m HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2023-02-21 P210022-S003 Alinity m CMV Real-Time Process PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2023-02-21 P200013-S010 Alinity m HBV Real-Time Process MKT Hepatitis Viral B Dna Detection Microbiology
2023-01-13 P200013-S012 Alinity m HBV Assay 30-Day Notice — — —
2023-01-13 P160044-S005 RealTime CMV Assay 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2022-12-22 P200013-S011 Alinity m HBV Special (Immediate Track) MKT Hepatitis Viral B Dna Detection Microbiology
2022-12-01 P170041-S006 Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime Normal 180 Day Track OWD — —
2022-11-28 P210022-S002 Alinity m CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2022-10-24 P200013-S009 Alinity m HBV Special (Immediate Track) MKT Hepatitis Viral B Dna Detection Microbiology
2022-06-28 P200013-S007 Alinity m HBV assay Real-Time Process MKT Hepatitis Viral B Dna Detection Microbiology
2022-06-09 P160044-S004 Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2022-06-08 P200013-S008 Alinity m HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2022-06-02 P170041-S004 Abbott RealTime IDH1 Normal 180 Day Track No User Fee OWD — —
2022-05-26 P210022-S001 Alinity m CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2022-05-05 P210022 Alinity m CMV Original PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2022-04-11 P170005-S004 Abbott RealTime IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit Special (Immediate Track) OWD — —
2022-03-18 P980024-S022 PathVysion HER-2 DNA Probe Kit 30-Day Notice MVD System, Test, Her-2/Neu, Nucleic Acid Or Serum Unknown
2022-03-18 P030052-S028 UroVysion Bladder Cancer Kit 30-Day Notice NSD Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence Unknown
2022-03-14 P200013-S006 Alinity m HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2021-06-01 P200013-S005 Alinity m HBV Real-Time Process MKT Hepatitis Viral B Dna Detection Microbiology
2021-06-01 P190025-S006 Alinity m HCV Real-Time Process MZP — —
2021-04-26 P200013-S002 Alinity m HBV Real-Time Process MKT Hepatitis Viral B Dna Detection Microbiology
2021-04-26 P190025-S004 Alinity m HCV Real-Time Process MZP — —
2021-03-08 P200013-S004 Alinity m HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2021-03-05 P200013-S003 Alinity m HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2021-03-05 P190025-S005 Alinity m HCV 30-Day Notice MZP — —
2021-03-05 P160044-S003 Abbott RealTime CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2021-03-05 P120012-S019 Abbott RealTime HCV Genotype II 30-Day Notice OBF Assay, Genotyping, Hepatitis C Virus Microbiology
2021-03-05 P100017-S024 Abbott RealTime HCV 30-Day Notice MZP — —
2021-03-05 P080026-S024 Abbott RealTime HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2021-03-03 P170041-S005 Abbott RealTime IDH1 30-Day Notice OWD — —
2021-03-03 P170005-S003 Abbott RealTime IDH2 30-Day Notice OWD — —
2021-01-19 P200013-S001 Alinity m HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2021-01-19 P190025-S003 Alinity m HCV 30-Day Notice MZP — —
2021-01-19 P170041-S003 Abbott RealTime IDH1 30-Day Notice OWD — —
2021-01-19 P170005-S002 Abbott RealTime IDH2 30-Day Notice OWD — —
2020-12-11 P980024-S021 PathVysion HER-2 DNA Probe Kit 30-Day Notice MVD System, Test, Her-2/Neu, Nucleic Acid Or Serum Unknown
2020-12-11 P150041-S006 Vysis CLL FISH Probe Kit 30-Day Notice PNK — —
2020-12-11 P110012-S021 Vysis ALK Break Apart FISH Probe Kit 30-Day Notice OWE — —
2020-12-11 P030052-S027 UroVysion Bladder Cancer Kit 30-Day Notice NSD Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence Unknown
2020-12-08 P100017-S023 Abbott RealTime HCV Assay 30-Day Notice MZP — —
2020-12-04 P080026-S023 Abbott RealTime HBV Assay 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2020-08-29 P200013 Alinity m HBV Original MKT Hepatitis Viral B Dna Detection Microbiology
2020-06-09 P190025-S002 Alinity m HCV 30-Day Notice MZP — —
2020-05-22 P110012-S020 Vysis ALK Break Apart Fish Probe Kit Normal 180 Day Track OWE — —
2020-05-06 P190025-S001 Alinity m HCV 30-Day Notice MZP — —
2020-03-23 P190025 Alinity m HCV Original MZP — —
Safety

Recalls (30)

Class I (serious)
5
Risk of injury / death
Total recalls
30
Currently ongoing
21
Most recent
2025-04-28
DateSeverityStatusRecall # ProductCodeReason
2025-04-28 Class II Ongoing Z-1749-2025 Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain … — There were reports of an increase in reactive negative controls and false positive results.
2025-04-28 Class II Ongoing Z-1748-2025 Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (… — There were reports of an increase in reactive negative controls and false positive results.
2025-03-20 Class II Ongoing Z-1665-2025 The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall a… — The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to …
2024-09-12 Class II Ongoing Z-0234-2025 Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF … — Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and A…
2024-09-12 Class II Ongoing Z-0233-2025 Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF… — Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and A…
2024-03-20 Class II Ongoing Z-1602-2024 Alinity m System, Part Number: 08N53-002 — The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system …
2024-02-01 Class III Ongoing Z-1190-2024 Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.) — Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
2024-02-01 Class III Ongoing Z-1189-2024 In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PT… — Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
2024-02-01 Class III Ongoing Z-1188-2024 In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319… — Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
2023-10-30 Class II Ongoing Z-0407-2024 Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro revers… — Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity…
2022-12-09 Class II Ongoing Z-1009-2023 Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes s… — The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their AD…
2022-11-22 Class II Ongoing Z-0740-2023 Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090 — Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
2022-11-22 Class II Ongoing Z-0739-2023 Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 — Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
2022-11-11 Class II Ongoing Z-1349-2023 Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4. — The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the in…
2022-10-12 Class II Ongoing Z-0268-2023 Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use — Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was foun…
2022-08-19 Class II Ongoing Z-1679-2022 Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In … — Reports received of an increase of message code 9186 (internal control failed) when using the kit.
2022-07-19 Class II Completed Z-1518-2022 The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. — Incorrect optical calibration
2022-03-04 Class II Ongoing Z-0884-2022 Alinity m HBV AMP Kit (US and CE) — There is a potential for misquantitation high results for negative samples.
2022-03-04 Class II Ongoing Z-0883-2022 Alinity m HBV Application Specification File (US and CE) — There is a potential for misquantitation high results of negative samples.
2022-02-11 Class II Terminated Z-0710-2022 Alinity m Integrated Reaction Units (IRU) — There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
2021-12-06 Class II Terminated Z-0463-2022 Alinity m System, Part No. 08N53-002 — There is an issue with the installation of updated camera firmware on the system.
2021-12-06 Class II Ongoing Z-0462-2022 Alinity m System, Part No. 08N53-002 — There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
2021-12-06 Class II Ongoing Z-0461-2022 Alinity m System, Part No. 08N53-002 — There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
2021-12-06 Class II Ongoing Z-0460-2022 Alinity m System, Part No. 08N53-002 — There is a potential for abnormal (non-sigmoidal) amplification curves.
2021-09-02 Class I Terminated Z-0008-2022 Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnost… — There is a potential for false positive results.
2021-09-02 Class I Terminated Z-0007-2022 Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic — There is a potential for false positive results.
2021-09-02 Class I Terminated Z-0006-2022 Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic — There is a potential for false positive results.
2021-09-02 Class I Terminated Z-0005-2022 Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specificatio… — There is a potential for false positive results.
2021-09-02 Class I Terminated Z-0004-2022 Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification … — There is a potential for false positive results.
2021-08-04 Class II Terminated Z-2576-2021 Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319,… — Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
Filings

All 510(k) clearances (11)

Date K-number Device Code Class Specialty
2025-09-25 K252102 Alinity m HCV MZP — —
2025-07-28 K243489 Alinity m EBV (09N43-095) QLX Class II Microbiology
2025-07-01 K243485 Alinity m CMV PAB Class II Microbiology
2025-03-24 K241921 Alinity m BKV QMI Class II Microbiology
2025-02-14 K241573 Alinity m Resp-4-Plex QOF Class II Microbiology
2025-01-30 K243410 simpli-COLLECT STI Test QYA — —
2024-12-06 K241580 Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) QQX Class II Microbiology
2024-05-03 K233349 Alinity m HSV 1 & 2 / VZV PGI — —
2023-03-03 K222379 Alinity m STI Assay QEP — —
2022-07-15 K212778 Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) QLX Class II Microbiology
2022-04-29 K202977 Alinity m STI Assay QEP — —
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence