Bio-Rad MONOLISA Anti-HBs EIA Recalled Due to Light Exposure Issues
Bio-Rad Laboratories is recalling MONOLISA Anti-HBs EIA kits because light exposure to the Conjugate Diluent may cause false positive or grey zone results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential diagnostic inaccuracy (false positives/grey zones) due to light exposure, which is a moderate risk without reported injuries or deaths.
Plain-English summary
Bio-Rad Laboratories is recalling approximately 7,400 units of the MONOLISA Anti-HBs EIA (catalog number 25220). This in vitro diagnostic product is used to detect antibody for hepatitis B surface antigen in human serum and plasma. The recall covers all lots distributed since May 5, 2007.
The recall was initiated because prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD). This issue can cause a negative sample to elevate to a grey zone or low positive result, potentially leading to inaccurate diagnostic outcomes.
The affected products were distributed worldwide, including nationwide in the United States and in Canada, South Africa, and Zimbabwe. Users should stop using the affected kits and contact Bio-Rad Laboratories for further instructions or replacement.
The recalled product
- 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…
- Manufacturer
- Bio-Rad Laboratories
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All lots distributed from May 5
- 2007
Distribution
Distributed nationwide across the United States.
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