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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Abbott Point Of Care Inc.: 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.

Agency Publication Date: January 19, 2021
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Affected Products

Product: Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25

Stored at room temperature (18 to 30¿C) for periods of time in excess of: 3 days for lot numbers *20100 to *20339 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y Primary GTIN (01) 00054749000163)

Lot Numbers:
numbers
numbers
letter
Product: Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25

Stored at room temperature (18 to 30¿C) for periods of time in excess of: 3 days for lot numbers *20100 to *20339 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y Primary GTIN (01) 00054749000163)

Lot Numbers:
numbers
numbers
letter

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87073
Status: Resolved
Manufacturer: Abbott Point Of Care Inc.
Manufactured In: United States
Units Affected: 2 products (2,820,000 cartridges US and 2,273,453 catridges OUS; 1,521,800 cartridges US and 2,641,053 cartridges OUS)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.