Recall Z-2398-2012— Bio-Rad Laboratories

Class II FDA medical device recall by Bio-Rad Laboratories, initiated 2012-07-27, terminated 2012-12-14. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 EIA 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 assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.. Reason: 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..

Recalling firm

Bio-Rad Laboratories

Classification

Class II

Status

Terminated

Initiated

2012-07-27

Terminated

2012-12-14

Firm location

Redmond, WA, United States

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