PlainRecalls

Abbott Point Of Care Inc.

Compiled from official public sources by the editorial team.

31 recalls on record · Latest: May 6, 2026

Abbott Point Of Care Inc. Recall Insight

Abbott Point Of Care Inc. appears on 31 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.030% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 6, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 31 entries, severity tagging shows 0 critical, 30 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 31 of 31 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (31). The date window on this page runs from Jul 18, 2012 to May 6, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate May 6, 2026

i-STAT G3+ cartridge; List Number: 03P78-26;

FDA Devices Moderate May 6, 2026

i-STAT EG7+ cartridge; List Number: 03P76-25;

FDA Devices Moderate May 6, 2026

i-STAT EG6+ cartridge; List Number: 03P77-25;

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 Sep 24, 2025

i-STAT EG7+ cartridge. List Number: 03P76-25.

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 Jan 27, 2021

Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in v…

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 Dec 26, 2018

Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Numb…

FDA Devices Moderate Mar 14, 2018

i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)

FDA Devices Moderate Aug 19, 2015

i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a b…

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 Moderate Dec 11, 2013

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 monitoring pati…

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 29, 2012

i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin …

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 15, 2012

i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardia…

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

i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium…

FDA Devices Moderate Jul 18, 2012

iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, …

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Compare Abbott Point Of Care Inc. with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.