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

Recall Z-1479-2024 — ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35

U.S. FDA — Device Enforcement · Germany · 2024-03-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1479-2024
Date of alert
2024-03-04
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Abbott GmbH
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00380740001414
Reported risk: Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).
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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