Recall Z-2398-2012 ยท LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Bio-Rad Laboratories
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
| Date | Sep 17, 2012 (initiated Jul 27, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Packaging |
| Action | The firm, Bio-Rad Laboratories, Inc., sent an "Important Product Information Bio-Rad MONOLISA Anti-HBs EIA Catalog #25220", letter dated 27 July 2012, to their domestic consignees/customers via FedEx. The International subsidiaries will be notified by e-mail. The consignees/customers were informed of the important storage and handling information regarding the MONOLISA Anti-HBs EIA Conjugate Diluent component . The consignees/customers were instructed to follow the storage and handling instructions as stated in the Package Insert, and compare their laboratories practices to the storage and |
| Quantity | 7,400 (approximately)- All lots since distribution date May 9, 2007 |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.