Abbott Point Of Care Inc.
19 recalls on record · Latest: Sep 24, 2025
FDA Devices Moderate Sep 24, 2025
i-STAT EG6+ cartridge. List Number: 03P77-25.
FDA Devices Moderate Sep 24, 2025
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
FDA Devices Moderate Sep 24, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Devices Moderate Jan 27, 2021
Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocri…
FDA Devices Moderate Feb 26, 2020
i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative …
FDA Devices Moderate Feb 26, 2020
i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative me…
FDA Devices Moderate Feb 26, 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 quantita…
FDA Devices Moderate Jan 8, 2020
i-STAT cTnI cartridge
FDA Devices Moderate Apr 2, 2014
i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic a…
FDA Devices Low Nov 14, 2012
Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control…
FDA Devices Moderate Aug 15, 2012
i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Na…
FDA Devices Moderate Aug 15, 2012
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anti…
FDA Devices Moderate Aug 15, 2012
i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatin…
FDA Devices Moderate Aug 8, 2012
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, pota…
FDA Devices Moderate Jul 18, 2012
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, p…
FDA Devices Moderate Jul 18, 2012
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocr…
FDA Devices Moderate Jul 18, 2012
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
FDA Devices Moderate Jul 18, 2012
Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized…
FDA Devices Moderate Jul 18, 2012