Enforcement Report - Week of September 26, 2012
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Product Detail
| Product Description | 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. |
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| Recall Number | Z-2398-2012 |
| Classification | Class II |
| Code Info | All lots distributed from May 5, 2007 |
| Product Distributed Qty | 7,400 (approximately)- All lots since distribution date May 9, 2007 |
| Reason For Recall | 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. |
Event Detail
| Event Id | 62850 |
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| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Bio-Rad Laboratories |
| City | Redmond |
| State | WA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-27 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe. |
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