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.

Recall Record: Class II Recall: i-STAT EG7+ cartridge; List Number: 03P76-25; by Abbott Point Of Care Inc.

At a glance: Abbott Point Of Care Inc. recalled i-STAT EG7+ cartridge; List Number: 03P76-25; on 2026-05-06. FDA classified this action as a Class II recall (recall number Z-1999-2026). Reason for recall: 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). Recall status: Ongoing. This is a device-category FDA recall record.

Key facts

Recalling firm	Abbott Point Of Care Inc.
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	i-STAT EG7+ cartridge; List Number: 03P76-25;
Classification	Class II
Recall number	Z-1999-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	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.

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 EG7+ cartridge; List Number: 03P76-25;. 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-1999-2026 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.

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 EG7+ cartridge; List Number: 03P76-25; -- and the recall number Z-1999-2026. 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.

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

What was recalled and why?: Abbott Point Of Care Inc. recalled i-STAT EG7+ cartridge; List Number: 03P76-25;. FDA's record states the reason for recall as: 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 logged under FDA recall number.
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 EG7+ cartridge; List Number: 03P76-25;) and recall number Z-1999-2026, 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.

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Full FDA history for Abbott Point Of Care Inc.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Recall Record: Class II Recall: i-STAT EG7+ cartridge; List Number: 03P76-25; by Abbott Point Of Care Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-abbott-point-of-care-inc-z-1999-2026

MLA

"Recall Record: Class II Recall: i-STAT EG7+ cartridge; List Number: 03P76-25; by Abbott Point Of Care Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-abbott-point-of-care-inc-z-1999-2026.

Chicago

Argus HQ Research. "Recall Record: Class II Recall: i-STAT EG7+ cartridge; List Number: 03P76-25; by Abbott Point Of Care Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-abbott-point-of-care-inc-z-1999-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_abbott_point_of_care_inc_z_1999_2026_2026,
  title = {Recall Record: Class II Recall: i-STAT EG7+ cartridge; List Number: 03P76-25; by Abbott Point Of Care Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-abbott-point-of-care-inc-z-1999-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗