Reported Sep 26, 2012 · Terminated
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a…
Bio-Rad Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bio-Rad Laboratories · 6565 185th Ave NE · Redmond, WA · 98052-5039
Is this the product you have?
- 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.
- Lot codes and dates
All lots distributed from May 52007
- Amount recalled
- 7,400 (approximately)- All lots since distribution date May 9, 2007
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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