Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.
This recall has been terminated (originally issued August 20, 2008).
- Company
- Bio-Rad Laboratories
- Recall Initiated
- January 7, 2008
- Posted
- August 20, 2008
- Terminated
- March 7, 2011
- Recall Number
- Z-1189-2008
- Quantity
- 31 distributed
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Lot Number 232BGG
Root 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.
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