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.
This recall has been terminated (originally issued May 20, 2010).
- Company
- Bio-Rad Laboratories
- Recall Initiated
- August 11, 2008
- Posted
- May 20, 2010
- Terminated
- May 20, 2010
- Recall Number
- Z-1620-2010
- Quantity
- 795 kits
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution -- USA and Canada.
Lot / Code Info
Lot #'s: 288BEE and 056CEE
Root Cause
Packaging process control
Action Taken
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.