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

Recall Z-2671-2014 — VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained wi

U.S. FDA — Device Enforcement · United Kingdom · 2014-08-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2671-2014
Date of alert: 2014-08-06
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: ORTHO-CLINICAL DIAGNOSTICS
Product category: device
Product type: Devices

Reported risk: VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approximate signal loss of up to 66.2% which can result in unexpected negative test results being obtained for reactive sample fluids (quality control and patient samples).

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.

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