Abbott Point Of Care Inc.: 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

Is my product affected?

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

• UPC 00054749000163

Check against the official notice below — it lists the full affected range.

What happened

Abbott Point of Care Inc. is recalling Abbott i-STAT CG8+ and EG7+ cartridges used to measure ionized calcium levels in blood samples. The cartridges may show falsely higher ionized calcium results when stored at room temperature (18 to 30 degrees Celsius) for extended periods. For lot numbers ending in *20100 to *20339, the problem occurs after storage exceeding 3 days, and for lot numbers *20340 and above, it occurs after storage exceeding 7 days, where the * represents lot letters A, K, L, M, N, W, or Y.

The recall affects approximately 2.8 million cartridges distributed in the United States and 2.3 million cartridges distributed outside the United States. The source document does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Nationwide Quantity: 2,820,000 cartridges US and 2,273,453 catridges OUS Lot/code info: 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)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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