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Abbott Point Of Care Inc. recalls Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH,
Recalled January 27, 2021 · FDA recall Z-0881-2021 · Abbott Point Of Care
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. · FDA Class II
Units
1,521,800 cartridges US and 2,641,053 cartridges OUS
Sold at
Nationwide
Description
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.
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
Manufacturer(s)
Abbott Point Of Care Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →