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FDAJune 10, 2021device

REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

There is a potential for 15% 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.

What to do

FDA enforcement status: Ongoing

Brands named

abbott laboratoriesabbott

UPCs

00380740132569

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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