Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2184-2021 — REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569

U.S. FDA — Device Enforcement · United States · 2021-06-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2184-2021
Date of alert
2021-06-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Laboratories
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00380740132569
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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