Chrysalis Intelligence · Sponsors · Abbott Point of Care, Inc.

Abbott Point of Care, Inc.

Princton, NJ, US · 18 510(k) clearances · 12 recalls

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Total clearances
18
2020-02-07 → 2026-06-26
Last 12 months
2
Product codes
9
Most recent
2026-06-26
Name variants in FDA filings: Abbott Point of Care / Abbott Point of Care, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
CHL — — — 4 2025-05-02
CGA — — — 4 2023-09-11
MMI Immunoassay Method, Troponin Subunit Class II Clinical Chemistry 2 2026-06-11
JGS Electrode, Ion Specific, Sodium Class II Clinical Chemistry 2 2023-10-27
JFP Electrode, Ion Specific, Calcium Class II Clinical Chemistry 2 2023-10-27
CGL Electrode, Ion Based, Enzymatic, Creatinine Class II Clinical Chemistry 1 2026-06-26
QAT Brain Trauma Assessment Test Class II Immunology 1 2024-03-27
JPI Device, Hematocrit Measuring Class II Hematology 1 2020-02-28
JFL — — — 1 2020-02-07
Safety

Recalls (12)

Class I (serious)
0
Risk of injury / death
Total recalls
12
Currently ongoing
7
Most recent
2026-04-01
DateSeverityStatusRecall # ProductCodeReason
2026-04-01 Class II Ongoing Z-2001-2026 i-STAT G3+ cartridge; List Number: 03P78-26; — Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cart…
2026-04-01 Class II Ongoing Z-2000-2026 i-STAT EG6+ cartridge; List Number: 03P77-25; — Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cart…
2026-04-01 Class II Ongoing Z-1999-2026 i-STAT EG7+ cartridge; List Number: 03P76-25; — Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cart…
2025-08-21 Class II Ongoing Z-2585-2025 i-STAT EG6+ cartridge. List Number: 03P77-25. — Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurem…
2025-08-21 Class II Ongoing Z-2584-2025 i-STAT EG7+ cartridge. List Number: 03P76-25. — Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurem…
2025-08-21 Class II Ongoing Z-2583-2025 i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300 — Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurem…
2025-08-21 Class II Ongoing Z-2582-2025 i-STAT CG4+ cartridge (white). List Number: 03P85-25. — Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.
2020-12-22 Class II Terminated Z-0881-2021 Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, … — Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for p…
2020-12-22 Class II Terminated Z-0880-2021 Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose… — Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for p…
2020-01-15 Class II Terminated Z-1263-2020 i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is i… — The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and …
2020-01-15 Class II Terminated Z-1262-2020 i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge… — The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and …
2020-01-14 Class II Terminated Z-1265-2020 i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be… — Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evidence to fully characterize the performance of the…
Filings

All 510(k) clearances (18)

Date K-number Device Code Class Specialty
2026-06-26 K261039 i-STAT Crea cartridge with the i-STAT 1 System CGL Class II Clinical Chemistry
2026-06-11 K253051 i-STAT hs-TnI cartridge with the i-STAT Alinity System MMI Class II Clinical Chemistry
2025-05-02 K244014 i-STAT CG4+ cartridge with the i-STAT 1 System CHL — —
2025-01-03 K240984 i-STAT hs-TnI cartridge with the i-STAT 1 System MMI Class II Clinical Chemistry
2024-03-27 K234143 i-STAT TBI Cartridge with the i-STAT Alinity System QAT Class II Immunology
2023-10-27 K230300 i-STAT CG8+ cartridge with the i-STAT 1 System JFP Class II Clinical Chemistry
2023-10-27 K230285 i-STAT CG8+ cartridge with the i-STAT 1 System CHL — —
2023-10-27 K230275 i-STAT CG8+ cartridge with the i-STAT 1 System JGS Class II Clinical Chemistry
2023-09-15 K223857 i-STAT G3+ cartridge with the i-STAT 1 System CHL — —
2023-09-11 K223755 i-STAT G cartridge with the i-STAT 1 System CGA — —
2023-07-28 K223710 i-STAT CG8+ cartridge with the i-STAT 1 System CGA — —
2021-08-13 K210958 i-STAT CHEM8+ cartridge with the i-STAT 1 System CGA — —
2020-04-09 K200492 i-STAT CG4+ Cartridge with the i-STAT 1 System CHL — —
2020-02-28 K183680 i-STAT CHEM8+ cartridge with the i-STAT 1 System JPI Class II Hematology
2020-02-14 K191360 i-STAT CHEM8+ cartridge with the i-STAT 1 System JFP Class II Clinical Chemistry
2020-02-07 K191298 i-STAT CHEM8+ cartridge with the i-STAT 1 System JFL — —
2020-02-07 K183688 i-STAT CHEM8+ cartridge with the i-STAT 1 System JGS Class II Clinical Chemistry
2020-02-07 K183678 i-STAT CHEM8+ cartridge with the i-STAT 1 System CGA — —
Data source: openFDA · Generated 2026-08-27 08:58 · Last ingest 2026-08-27T12:58:10.687222 · Pipeline: Chrysalis Intelligence