Abbott Point of Care, Inc.
Abbott Point of Care, Inc. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2026, with 31 FDA device recalls on record.
Top product codes for Abbott Point of Care, Inc.
FDA recalls by Abbott Point of Care, Inc.
10 most recent of 31- Z-2001-2026 — i-STAT G3+ cartridge; List Number: 03P78-26;
- Z-1999-2026 — i-STAT EG7+ cartridge; List Number: 03P76-25;
- Z-2000-2026 — i-STAT EG6+ cartridge; List Number: 03P77-25;
- Z-2583-2025 — i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
- Z-2584-2025 — i-STAT EG7+ cartridge. List Number: 03P76-25.
- Z-2585-2025 — i-STAT EG6+ cartridge. List Number: 03P77-25.
- Z-2582-2025 — i-STAT CG4+ cartridge (white). List Number: 03P85-25.
- Z-0881-2021 — Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25
- Z-0880-2021 — Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25
- Z-1262-2020 — i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantitative measurement of sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine, and hematocrit in venous, arterial or capillary whole blood.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Abbott Point of Care, Inc.
- K261039 — i-STAT Crea cartridge with the i-STAT 1 System
- K253051 — i-STAT hs-TnI cartridge with the i-STAT Alinity System
- K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System
- K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System
- K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System
- K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System
- K230300 — i-STAT CG8+ cartridge with the i-STAT 1 System
- K223857 — i-STAT G3+ cartridge with the i-STAT 1 System
- K223755 — i-STAT G cartridge with the i-STAT 1 System
- K223710 — i-STAT CG8+ cartridge with the i-STAT 1 System
- K210958 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K200492 — i-STAT CG4+ Cartridge with the i-STAT 1 System
- K183680 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K191360 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K183678 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K183688 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K191298 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K163271 — i-Stat Alinity System with i-Stat Glucose test
- K153357 — i-STAT Alinity System with i-STAT Sodium test
- K133002 — i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
- K103195 — I-STAT 1 WIRELESS ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.