medical Class II Updated 2021-08-11

Abbott Laboratories recalls REF 8L92-22, Abbott Activated Alanine aminotransferase, for

Recalled Product

REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859


Hazard / Issue

There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers / Expiration Date 02954UN20 / 29AUG2021 37921UN20 / 01DEC2021 81823UN21 / 16FEB2022
View official government recall

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