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Use caution Medical device recall · FDA · Published April 1, 2026

Abbott i-STAT G3+ Cartridges May Show Wrong Blood Gas Results

Abbott recalls i-STAT G3+ cartridges with list number 03P78-26 that may show falsely high CO2 and low pH, risking unnecessary medical interventions. Affected units may need replacement.

🇺🇸 FDA recall #Z-2001-2026Medical deviceAbbott ›
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Recalling firmAbbott Point Of Care Inc.400 College Rd E · Princeton, NJ 08540-6607
✎ GovInfoNow plain-language explainer

Abbott is recalling i-STAT G3+ blood gas cartridges that could show incorrect blood gas results, potentially leading to harmful medical decisions. This affects specific lots sold in the U.S. and requires replacement to avoid risks like unnecessary ventilator changes or medication. Read more at govinfonow.com/recall/49571-abbott-i-stat-g3-cartridges-may-show-wrong-blood-gas.

Source Summary by GovInfoNow · govinfonow.com/recall/49571-abbott-i-stat-g3-cartridges-may-show-wrong-blood-gas · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2001-2026

Cite this page

“Abbott i-STAT G3+ Cartridges May Show Wrong Blood Gas Results.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49571-abbott-i-stat-g3-cartridges-may-show-wrong-blood-gas. Based on FDA recall #Z-2001-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2001-2026%22&limit=1).

The FDA announced on April 1, 2026, that Abbott Point Of Care Inc. is recalling i-STAT G3+ cartridges (List Number: 03P78-26) due to a manufacturing issue causing inaccurate blood gas results. Owners should stop using the affected lots immediately.

How to tell if you have it

  • Brand: Abbott
  • Product: i-STAT G3+ cartridge
  • List Number: 03P78-26
  • UDI-DI: 00054749005673
  • Lot number: N25221
  • Units affected: 40,275

The hazard

Approximately 7.6% of the recalled cartridges may report higher than expected PCO2 and lower than expected pH results. This inaccuracy can make blood gas appear as if a patient is in severe respiratory acidosis, potentially triggering unnecessary or harmful interventions such as ventilator changes or medications.

Context

GovInfoNow's records show Abbott Point Of Care Inc. has 8 other recalls on record since September 12, 2017. Other recent recalls of similar products include the Abbott i-STAT CG4+ Cartridge Recall (August 21, 2025), the Abbott i-STAT EG6+ Cartridge Recall (August 21, 2025), and the Abbott i-STAT CG8+ Cartridges recall (December 22, 2020). Other recent recalls of similar products include the Siemens Epoc Blood Test Cards recall (April 2, 2026), the Abbott Diabetes Care FreeStyle Libre 3 Plus Sensor Recall (November 24, 2025), and the Beckman Coulter Bicarbonate Reagent recall (October 14, 2025).

How to tell if you have this one

Check for list number 03P78-26 on the cartridge packaging. The affected units were sold in the U.S. with UDI-DI 00054749005673 and lot number N25221.

  • Brand
    Abbott
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the countries of Canada, AUSTRIA, BANGLADESH, BELGIUM, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, LUXEMBOURG, MAURITIUS, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM.
Recall numberProduct, codes & lotsQuantity
Z-1999-2026i-STAT EG7+ cartridge; List Number: 03P76-25;; List Number: 03P76-25; UDI-DI: 00054749000043; Lot numbers: N25206, N25207, N25209, N25213, N25218, N25219, N25233;369650 units (150875 US, 218775 OUS)
Z-2000-2026i-STAT EG6+ cartridge; List Number: 03P77-25;; List Number: 03P77-25; UDI-DI: 00054749000050; Lot number: N25223A;30775 units (25625 US, 5150 OUS)
Z-2001-2026i-STAT G3+ cartridge; List Number: 03P78-26;; List Number: 03P78-26; UDI-DI: 00054749005673; Lot number: N25221;40275 units (US only)
Based on the official FDA remedy

What to do — step by step

  1. Check Cartridge Details

    Look for list number 03P78-26 on the cartridge packaging to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, AUSTRIA, BANGLADESH, BELGIUM, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, LUXEMBOURG, MAURITIUS, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 35 days after the firm started it.

1. Firm started the recall: Apr 1, 202612. FDA classified it Class II: Apr 29, 202623. Published in FDA’s Enforcement Report: May 6, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2001-2026 (April 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2001-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA