Z-0881-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2021
- Initiation Date
- December 22, 2020
- Termination Date
- September 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,521,800 cartridges US and 2,641,053 cartridges OUS
Product Description
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
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 Pattern
Nationwide
Code Information
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)