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

Recall Z-0772-2024 — VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926

U.S. FDA — Device Enforcement · United States · 2023-11-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0772-2024
Date of alert
2023-11-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ortho-Clinical Diagnostics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10758750001682
Reported risk: Affected lots may experience increased calibration failures or an increase in falsely elevated 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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