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

Recall Z-2187-2021 — REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866

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-2187-2021
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)
00380740161866
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.