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

Recall Z-0557-2014 — VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs

U.S. FDA — Device Enforcement · United States · 2013-10-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0557-2014
Date of alert
2013-10-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ortho-Clinical Diagnostics
Product category
device
Product type
Devices
Reported risk: Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive 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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