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

Recall Z-1728-2020 — ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.

U.S. FDA — Device Enforcement · Germany · 2020-03-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1728-2020
Date of alert
2020-03-09
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Abbott Gmbh & Co. KG
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00380740011185
Reported risk: An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
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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