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

Recall Z-1161-2013 — VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.

U.S. FDA — Device Enforcement · United States · 2012-11-01 · Class III

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1161-2013
Date of alert
2012-11-01
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Ortho-Clinical Diagnostics
Product category
device
Product type
Devices
Reported risk: Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.
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.

Related

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.