Recall Z-1620-2010 ยท LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Bio-Rad Laboratories
Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA 25220; MONOLISA TM Anti-HBs Calibrator Kit 25219... Bio-Rad Laboratories Redmond, WA 98052" For the qualitative detection of antibody to Hepatitis B Surface Antigen (anti-HBs) in Human Serum and EDTA or citrated plasma.
| Date | May 20, 2010 (initiated Aug 11, 2008) |
| Status | Terminated |
| Reason | The package insert provided with this kit contains a typographical error, giving incorrect directions to prepare a Working Conjugate Solution. If these directions are followed, it would result in a 1:6 dilution and invalidate the assay. |
| Root cause | Packaging process control |
| Action | All domestic customers were notified via an Urgent Product Correction customer letter sent by DHL or FedEx on 8/11/08. Enclosed with the letter was a corrected package insert. The Canadian subsidiary was notified via e-mail on 8/11/08. The letter advised customers of the correct wording, and advised that a new corrected package insert was enclosed and to make note of the correction in the laboratory procedures. Questions should be directed to Bio-Rad Laboratories Technical Support at 1-800-224-6723. |
| Quantity | 795 kits |
| Distribution | Worldwide Distribution -- USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.