Abbott Point recalls
Abbott Point appears in 32 official U.S. recall notices indexed by RecallRadar, most recently on 2026-05-06.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 32 |
|---|---|
| Published | 2012-07-18 to 2026-05-06 |
| By agency | FDA Device (32) |
| By classification | Class II (31), Class III (1) |
| By status | terminated (25), ongoing (7) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- i-STAT G3+ cartridge
FDA Device · Class II · 2026-05-06 · Abbott Point
Reason: 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) cartridge lots in the U.S. marketplace may report higher than e… - i-STAT EG6+ cartridge
FDA Device · Class II · 2026-05-06 · Abbott Point
Reason: 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) cartridge lots in the U.S. marketplace may report higher than e… - i-STAT EG7+ cartridge
FDA Device · Class II · 2026-05-06 · Abbott Point
Reason: 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) cartridge lots in the U.S. marketplace may report higher than e… - i-STAT CG4+ cartridge (white)
FDA Device · Class II · 2025-09-24 · Abbott Point
Reason: 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. - i-STAT EG6+ cartridge
FDA Device · Class II · 2025-09-24 · Abbott Point
Reason: 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 measurement ranges for pH and PO2. - i-STAT CG8+ cartridge
FDA Device · Class II · 2025-09-24 · Abbott Point
Reason: 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 measurement ranges for pH and PO2. - i-STAT EG7+ cartridge
FDA Device · Class II · 2025-09-24 · Abbott Point
Reason: 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 measurement ranges for pH and PO2. - Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and…
FDA Device · Class II · 2021-01-27 · Abbott Point
Reason: 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 periods of time in excess of 3 days for lot numbers *20100 t… - Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hemato…
FDA Device · Class II · 2021-01-27 · Abbott Point
Reason: 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 periods of time in excess of 3 days for lot numbers *20100 t… - i-STAT CHEM8+ cartridges (blue), List No. 09P31-25
FDA Device · Class II · 2020-02-26 · Abbott Point
Reason: 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 non-waived. Different CLIA standards apply to waived and non-w… - i-STAT CG4+ cartridge (blue), List No. 03P85-50
FDA Device · Class II · 2020-02-26 · Abbott Point
Reason: 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 non-waived. Different CLIA standards apply to waived and non-w… - i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quant…
FDA Device · Class II · 2020-02-26 · Abbott Point
Reason: 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 blue i-STAT G3+ cartridges and therefore will no longer dist… - i-STAT cTnI cartridge
FDA Device · Class II · 2020-01-08 · Abbott Point
Reason: i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range. - Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood
FDA Device · Class II · 2018-12-26 · Abbott Point
Reason: Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be generated. When testing with s… - i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
FDA Device · Class II · 2018-03-14 · Abbott Point
Reason: Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges, Action Ranges, and Custom Reportable Ranges are reset to factory… - i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch
FDA Device · Class II · 2015-08-19 · Abbott Point
Reason: Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/INR. - i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and meta…
FDA Device · Class II · 2014-04-02 · Abbott Point
Reason: Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results. - Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitori…
FDA Device · Class II · 2013-12-11 · Abbott Point
Reason: Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR. - Abbott Point of Care i-Stat cTnI cartridge
FDA Device · Class II · 2013-01-30 · Abbott Point
Reason: APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack. - Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09
FDA Device · Class III · 2012-11-14 · Abbott Point
Reason: Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039); i-STAT Level 2 (List #06F12-10; Lot Number 081039); and i-STAT Lev… - i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac tropo…
FDA Device · Class II · 2012-08-29 · Abbott Point
Reason: Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information r… - i-Stat cTnl cartridges Abbott Point of Care Inc
FDA Device · Class II · 2012-08-15 · Abbott Point
Reason: The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. - i-Stat BNP cartridges Abbott Point of Care Inc
FDA Device · Class II · 2012-08-15 · Abbott Point
Reason: The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. - I-STAT PT/INR cartridge Abbott Point of Care Inc
FDA Device · Class II · 2012-08-15 · Abbott Point
Reason: The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results. - i-Stat CK-MP cartridges Abbott Point of Care Inc
FDA Device · Class II · 2012-08-15 · Abbott Point
Reason: The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. - I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodiu…
FDA Device · Class II · 2012-08-08 · Abbott Point
Reason: i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer. - Military Kit Portable Clinical Analyzer
FDA Device · Class II · 2012-07-18 · Abbott Point
Reason: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. - i-STAT1 Abaxis Analyzer
FDA Device · Class II · 2012-07-18 · Abbott Point
Reason: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. - iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200
FDA Device · Class II · 2012-07-18 · Abbott Point
Reason: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. - i-Stat Portable Clinical Analyzer
FDA Device · Class II · 2012-07-18 · Abbott Point
Reason: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. - i-STAT1 Abaxis Analyzer
FDA Device · Class II · 2012-07-18 · Abbott Point
Reason: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. - Fuso Analyzer 300F
FDA Device · Class II · 2012-07-18 · Abbott Point
Reason: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.