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

Recall Z-2398-2012 — The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs

U.S. FDA — Device Enforcement · United States · 2012-07-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2398-2012
Date of alert: 2012-07-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Bio-Rad Laboratories
Product category: device
Product type: Devices

Reported risk: Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result.

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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