FDA-Device2021-01-27Class II
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
Abbott Point Of Care Inc.
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.
Sold states
Nationwide
Affected count
1,521,800 cartridges US and 2,641,053 cartridges OUS
Manufactured in
400 College Rd E, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0881-2021Don't want to check this manually?
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