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i-STAT 03P88-25

by Abbott Point of Care Inc.

Ref 03P88-25

i-STAT 03P88-25 is a device classified as IVD General (EU), Class II (US) made by Abbott Point of Care Inc., registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-00054749000166), cleared under FDA 510(k) K230275 on 27 Oct 2023 (4 earlier submissions) and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00054749000166), active as of 7 Nov 2026. 19 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

None, self-declared

Class I: no certifier involved

510(k) K230275

+4 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00054749000166 Basic UDI-DI 00054749000166UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK230275 Date27 Oct 2023DecidedStatusActive
United StatesGUDID listing GUDID Number00054749000166 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00054749000166 registered 28 Oct 2026 Active
  • FDA 510(k) K230275 decided 27 Oct 2023 Active· +4 more in the status table
  • FDA GUDID UDI-DI 00054749000166 listed 9 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

19 recalls · 3 ongoing · FDA

  • 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
    • Terminated Z-1794-2010 FDA Unclassified (pre-2012) initiated 5 Feb 2010

    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.

Timeline

26 dated events

  1. Recall initiated FDA recalls Z-0881-2021
  2. Recall initiated FDA recalls Z-0880-2021
  3. Cleared FDA 510(k) K223710
  4. Cleared FDA 510(k) K230275
  5. Cleared FDA 510(k) K230285
  6. Cleared FDA 510(k) K230300
  7. Recall initiated FDA recalls Z-2582-2025
  8. Recall initiated FDA recalls Z-1999-2026
  9. Recall initiated FDA recalls Z-2000-2026
  10. Registered EUDAMED B-00054749000166

16 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
i-STAT CG8+ Cartridge EUDAMED
i-STAT GUDID
Generic name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Model / Ref / Catalog
03P88-25
Primary DI / UDI-DI
00054749000166 EUDAMED
10054749000163 GUDID
Basic UDI-DI
B-00054749000166
510(k) Number
FDA product code
CHL, CGA, CEM, JFP, JGS, JJE, JPI
EMDN code
W0101060609 Blood gas incl. electrolytes / metabolites - unitary use cassette
GMDN term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1120, 862.1345, 862.1600, 862.1145, 862.1665, 862.2160, 864.6400
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00054749000166
GUDID
10054749000163
Device classEUDAMED
Class IVD General
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00054749000166; FDA GUDID lists 10054749000163), so their flags are not compared. Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagentBlood gas/haemoximetry analyser IVD, point-of-careSodium (Na+) electrode IVDPotassium (K+) electrode IVD

Cleared under the same submission (K940918)

Similar devices in this category

Other devices filed under ELECTRODES OR CASSETTES FOR BLOOD GAS ANALYSIS INCL. ELECTROLYTES / METABOLITES - POC.

Other devices from Abbott Point of Care Inc.

See all devices from Abbott Point of Care Inc. →

Properties

  • Single use
  • Contains latex
  • Contains substances of microbial origin
  • Near-patient testing
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)