Abbott Point Of Care Inc.
Princeton, NJ
This page shows every FDA and USDA recall linked to Abbott Point Of Care Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
64
Total Recalls
2006
First Recall
2025
Most Recent
i-STAT EG7+ cartridge. List Number: 03P76-25.
Sep 17, 2025
· Device
Active
i-STAT CG8+ cartridge. List Number: 03P88-25.
510(k) numbers: K894914, K940918, K223710, K230275, K230285,...
Sep 17, 2025
· Device
Active
i-STAT EG6+ cartridge. List Number: 03P77-25.
Sep 17, 2025
· Device
Active
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Sep 17, 2025
· Device
Active
Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized cal...
Dec 22, 2020
· Device
Terminated
Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calciu...
Dec 22, 2020
· Device
Terminated
i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+...
Feb 18, 2020
· Device
Terminated
i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cart...
Feb 18, 2020
· Device
Terminated
i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartri...
Feb 18, 2020
· Device
Terminated
i-STAT cTnI cartridge
Oct 16, 2019
· Device
Terminated
Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous...
Sep 13, 2018
· Device
Terminated
i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (...
Sep 12, 2017
· Device
Terminated
i-Stat PT/INR Cartridges
List number 03P89-24
The cartridges are packaged in sealed pouches, one per pouch....
Aug 10, 2015
· Device
Terminated
i-STAT G3+ Cartridge
pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of res...
Mar 27, 2014
· Device
Terminated
Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540
The i-Stat PT a prothrombin ti...
Dec 4, 2013
· Device
Terminated
Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039)
Clini...
Nov 2, 2012
· Device
Terminated
i-STAT cTnI cartridges
Product Usage:
The i-STAT cTnl test is an in vitro diagnostic test for the quantitati...
Aug 22, 2012
· Device
Terminated
i-Stat cTnl cartridges
Abbott Point of Care Inc.
The i-Stat cTnl test is an in vitro diagnostic test for the...
Aug 9, 2012
· Device
Terminated
i-Stat BNP cartridges
Abbott Point of Care Inc.
The i-Stat BNP test is an in vitro diagnostic test for the q...
Aug 9, 2012
· Device
Terminated
i-Stat CK-MP cartridges
Abbott Point of Care Inc.
The i-Stat CKMB test is an in vitro diagnostic test for the...
Aug 9, 2012
· Device
Terminated
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA
This cartridge is useful for mo...
Aug 8, 2012
· Device
Terminated
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ.
The i-Stat EG7 cartridge is intended to be used fo...
Aug 2, 2012
· Device
Terminated
i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests f...
Jul 9, 2012
· Device
Terminated
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
Jul 9, 2012
· Device
Terminated
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests for sodium,...
Jul 9, 2012
· Device
Terminated
iStat1 Analyzer
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests for sodium, potassiu...
Jul 9, 2012
· Device
Terminated
Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree...
Jul 9, 2012
· Device
Terminated
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests for sodium, pota...
Jul 9, 2012
· Device
Terminated
i-Stat cTnI cartridges
Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I...
Nov 10, 2011
· Device
Terminated
i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110
Useful for monitoring a variety of conditions. Th...
Apr 18, 2011
· Device
Terminated
Cardiac Marker Control Level 1, List Number 136601-06F12-02; Cardiac Marker Control Level 2, List number 13660...
Apr 1, 2011
· Device
Terminated
Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02.
Used to verify the accuracy...
Apr 1, 2011
· Device
Terminated
i-STAT G3+ Cartridge: PCO2
Abbott Point of Care,
Princeton, NJ 08540
The test for PCO2, as part of the i-STAT...
Mar 10, 2011
· Device
Terminated
Celite ACT Cartridge
Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary...
Feb 16, 2011
· Device
Terminated
i-STAT Level 2 Control Value Assignment Sheets
Human Consumption
Feb 2, 2011
· Device
Terminated
i-STAT CG8+ Cartridge;
pH, pCO2, PO2, NA, K, iCa, Glu, Hct; IVD
Abbott Point of Care
The test for PCO2, as pa...
Jan 20, 2011
· Device
Terminated
i-STAT G3+ Cartridge;
pH, pCO2, PO2; IVD
Abbott Point of Care
The test for PCO2, as part of the i-STAT System...
Jan 20, 2011
· Device
Terminated
Military Kit Portable Clinical Analyzer;
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree 3...
Dec 10, 2010
· Device
Terminated
Military Kit i-STAT1;
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree 37 degree C tests for...
Dec 10, 2010
· Device
Terminated
i-STAT Analyzer;
Abbott Point of Care, Princeton, NJ 08540
Model 200. the 37 degree 37 degree C tests for sodi...
Dec 10, 2010
· Device
Terminated
FUSO Analyzer 300F
Abbott Point of Care, Princeton, NJ 08540
Model 200. the 37 degree 37 degree C tests for s...
Dec 10, 2010
· Device
Terminated
i-STAT1 Abaxis Analyzer;
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree 37 degree C tests...
Dec 10, 2010
· Device
Terminated
i-STAT Portable Clinical Analyzer;
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree 37 degre...
Dec 10, 2010
· Device
Terminated
i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Prin...
Nov 24, 2010
· Device
Terminated
i-STAT ACT Celite Cartridges
in vitro diagnostic test used to monitor moderate and high-level heparin therapy...
Nov 17, 2010
· Device
Terminated
i-STAT ACT Kaolin Cartridges
in vitro diagnostic test which uses fresh whole blood to monitor high-dose hepari...
Nov 17, 2010
· Device
Terminated
i-STAT cTnl cartridge
Abbott Point of Care,
Princeton, NJ 08540
Nov 3, 2010
· Device
Terminated
i-STAT CK-MB cartridge
Abbott Point of Care,
Princeton, NJ 08540
Nov 3, 2010
· Device
Terminated
i-STAT BNP cartridge
Abbott Point of Care,
Princeton, NJ 08540
Nov 3, 2010
· Device
Terminated
GCX Mountable Downloader-Recharger;
(accessory to the i-STAT Portable Clinical Analyzer (model 300).
The GCX M...
Sep 23, 2010
· Device
Terminated