Recall Z-1189-2008
Bio-Rad Laboratories · initiated January 7, 2008
Product
Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.
Codes / lots: Lot Number 232BGG
Reason for recall
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1189-2008
- Initiated
- January 7, 2008
- Posted by FDA
- August 20, 2008
- Terminated
- March 7, 2011
- Quantity
- 31 distributed
- Distribution
- Nationwide Distribution.
- Recalling firm
- Bio-Rad Laboratories, Redmond, WA