FDA Recall
Terminated
Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.
Recall: Z-1189-2008
·
Initiated January 7, 2008
Recall
- Recall Number
- Z-1189-2008
- Event Number
- 46728
- Firm
- Bio-Rad Laboratories
- FEI Number
- 3008272466
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- January 7, 2008
- Posted
- August 20, 2008
- Terminated
- March 7, 2011
- Address
- 6565 185th Ave NE, Redmond, WA, 98052-5039
Description
Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.
Reason
Incorrect result: Elevated reactivity with a kit lot 232BGG. Patient samples that are negative for antibodies to anti-HBc could be assigned a positive result.
Action
Bio-Rad called each customer and alerted them to the issue on 1/7-8/2008. A letter was faxed and sent via overnight carrier (DHL) to each customer site on 1/8/2008. Customers were told not to use the affected lot of the product and to discard it. The firm will provide another lot of the product to customers.
Distribution
Nationwide Distribution.
Quantity
31 distributed