Abbott Point Of Care Inc.
Complete recall history across all FDA and CPSC categories — 28 total recalls
Abbott Point Of Care Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (28)
FDA medical device enforcement actions by Abbott Point Of Care Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Aug 21, 2025 | i-STAT EG7+ cartridge. List Number: 03P76-25. | Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartr... | Class II |
| Aug 21, 2025 | i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K... | Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartr... | Class II |
| Aug 21, 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... | Class II |
| Aug 21, 2025 | i-STAT EG6+ cartridge. List Number: 03P77-25. | Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartr... | Class II |
| Dec 22, 2020 | Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement ... | Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit high... | Class II |
| Dec 22, 2020 | Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of ... | Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit high... | Class II |
| Jan 15, 2020 | i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 -... | The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not hav... | Class II |
| Jan 15, 2020 | i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Pr... | The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not hav... | Class II |
| Jan 14, 2020 | i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Pro... | Marketed without a 510(k). Abbott Point of Care has determined that it does ... | Class II |
| Oct 16, 2019 | i-STAT cTnI cartridge | i-STAT¿ cTnI blue cartridges may generate a higher than expected number of qu... | Class II |
| Sep 13, 2018 | Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification... | Inaccurate potassium results may be generated. When testing with control flui... | Class II |
| Sep 12, 2017 | i-STAT DE handheld data processing module for clinical use, Software Version ... | Issues resulting from upgrade to software version 2.8: (1) Location, operator... | Class II |
| Jun 15, 2015 | i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged ... | Certain lots of PT/INR cartridges may generate a higher than typical number o... | Class II |
| Jan 1, 2014 | i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnos... | Abbott Point of Care has determined that some individual patient results gene... | Class II |
| Oct 28, 2013 | Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 0854... | Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges ... | Class II |
| Jul 19, 2012 | Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06... | Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Car... | Class III |
| Mar 7, 2012 | i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vit... | Abbott Point of Care has determined that i-Stat CTNL cartridges have the pote... | Class II |
| Mar 1, 2012 | I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA... | The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevat... | Class II |
| Feb 1, 2012 | i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test i... | The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges... | Class II |
| Feb 1, 2012 | i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is... | The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges... | Class II |
| Feb 1, 2012 | i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is a... | The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges... | Class II |
| Sep 8, 2011 | iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The ... | Some i-Stat Analyzers become uncomfortably hot to touch in the are of the bat... | Class II |
| Sep 8, 2011 | i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 ... | Some i-Stat Analyzers become uncomfortably hot to touch in the are of the bat... | Class II |
| Sep 8, 2011 | Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, N... | Some i-Stat Analyzers become uncomfortably hot to touch in the are of the bat... | Class II |
| Sep 8, 2011 | i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 | Some i-Stat Analyzers become uncomfortably hot to touch in the are of the bat... | Class II |
| Sep 8, 2011 | i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 2... | Some i-Stat Analyzers become uncomfortably hot to touch in the are of the bat... | Class II |
| Sep 8, 2011 | Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. T... | Some i-Stat Analyzers become uncomfortably hot to touch in the are of the bat... | Class II |
| Jan 1, 2011 | I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 ... | i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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