FDA Class II Recall: i-STAT G3+ cartridge; List Number: 03P78-26; by Abbott Point Of Care Inc. — Recall Details

Key facts

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- i-STAT G3+ cartridge; List Number: 03P78-26; -- and the recall number Z-2001-2026. If it matches, stop using or distributing it and contact Abbott Point Of Care Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Abbott Point Of Care Inc. and the affected product is described in FDA's record as: i-STAT G3+ cartridge; List Number: 03P78-26;. FDA's stated reason for the recall is: 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 (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2001-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

Abbott Point Of Care Inc.’s FDA history

Argus HQ has recorded 3 total FDA actions tied to Abbott Point Of Care Inc.: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (i-STAT G3+ cartridge; List Number: 03P78-26;) and recall number Z-2001-2026, then follow Abbott Point Of Care Inc.'s recall instructions.

Has Abbott Point Of Care Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 3 total FDA actions tied to Abbott Point Of Care Inc., including 3 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-2001-2026.

Related enforcement actions