Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Recalled by Bio-Rad Laboratories Due to Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bio-Rad Laboratories directly.
Affected Products
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.
Quantity: 7,400 (approximately)- All lots since distribution date May 9, 2007
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bio-Rad Laboratories
Bio-Rad Laboratories has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report