i-STAT 03P79-25

• FDA 510(k) K940918 decided 10 May 1994 Active
• FDA GUDID UDI-DI 10054749000071 listed 9 Sep 2016 Listed

• 2 recalls, same reason

  • Ongoing Z-1999-2026 FDA Class II ·initiated 1 Apr 2026
  • Ongoing Z-2000-2026 FDA Class II ·initiated 1 Apr 2026

  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 expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.

• • Ongoing Z-2582-2025 FDA Class II ·initiated 21 Aug 2025

  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.

• 2 recalls, same reason

  • Terminated Z-0881-2021 FDA Class II ·initiated 22 Dec 2020
  • Terminated Z-0880-2021 FDA Class II ·initiated 22 Dec 2020

  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 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.

• • Terminated Z-0615-2019 FDA Class II ·initiated 13 Sep 2018

  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 samples with a high concentration of potassium, decreased potassium results may be generated

• • Terminated Z-1306-2014 FDA Class II ·initiated 1 Jan 2014

  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.

• • Terminated Z-2133-2012 FDA Class II ·initiated 1 Jan 2011

  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.

• 4 recalls, same reason

  • Terminated Z-0594-2011 FDA Unclassified (pre-2012) ·initiated 20 Sep 2010
  • Terminated Z-0593-2011 FDA Unclassified (pre-2012) ·initiated 20 Sep 2010
  • Terminated Z-0596-2011 FDA Unclassified (pre-2012) ·initiated 20 Sep 2010
  • Terminated Z-0595-2011 FDA Unclassified (pre-2012) ·initiated 20 Sep 2010

  i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.

• 2 recalls, same reason

  • Terminated Z-0930-2011 FDA Unclassified (pre-2012) ·initiated 3 Aug 2010
  • Terminated Z-0929-2011 FDA Unclassified (pre-2012) ·initiated 3 Aug 2010

  Two cartridge lots were identified that may generate falsely elevated PCO2 results.

• 2 recalls, same reason

  • Terminated Z-1793-2010 FDA Unclassified (pre-2012) ·initiated 5 Feb 2010 ·on shared 510(k) K940918
  • Terminated Z-1794-2010 FDA Unclassified (pre-2012) ·initiated 5 Feb 2010 ·on shared 510(k) K940918

  Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.

• 2 recalls, same reason

  • Terminated Z-1541-2009 FDA Unclassified (pre-2012) ·initiated 23 Feb 2009
  • Terminated Z-1540-2009 FDA Unclassified (pre-2012) ·initiated 23 Feb 2009

  Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.

• • Terminated Z-1621-2011 FDA Unclassified (pre-2012) ·initiated 25 Sep 2006

  Certain lots of G3+ cartridges may be difficult to fill.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 20 Sep 2010 Recall initiated FDA recalls Z-0595-2011
2. 1 Jan 2011 Recall initiated FDA recalls Z-2133-2012
3. 1 Jan 2014 Recall initiated FDA recalls Z-1306-2014
4. 9 Sep 2016 Listed FDA GUDID 10054749000071
5. 13 Sep 2018 Recall initiated FDA recalls Z-0615-2019
6. 22 Dec 2020 Recall initiated FDA recalls Z-0881-2021
7. 22 Dec 2020 Recall initiated FDA recalls Z-0880-2021
8. 21 Aug 2025 Recall initiated FDA recalls Z-2582-2025
9. 1 Apr 2026 Recall initiated FDA recalls Z-1999-2026
10. 1 Apr 2026 Recall initiated FDA recalls Z-2000-2026

11 earlier events are in the sections above.

Trade name

i-STAT

Generic name

Potassium (K+) electrode IVD

Model / Ref / Catalog

03P79-25

Primary DI / UDI-DI

10054749000071

510(k) Number

K940918 ↗

FDA product code

CHL

GMDN term

Potassium (K+) electrode IVD

Device class

Class II

Regulation number

862.1120

GUDID distribution status

In Commercial Distribution

Category: Urea IVD, reagent,Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent,Blood gas/haemoximetry analyser IVD, point-of-care,Sodium (Na+) electrode IVD

• i-STAT Alinity Printer Kit

  Class A

  CE/IVDR

• i-STAT Electronic Simulator

  Class A

  CE/IVDR

• i-STAT Alinity Base Station

  Class A

  CE/IVDR

• i-STAT 1 Downloader/Recharger Kit

  Class A

  CE/IVDR

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