Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.
FDA device recall Z-1189-2008 · posted 2008-08-20 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Quantity affected
- 31 distributed
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-01-07
- Date posted
- 2008-08-20
- Date terminated
- 2011-03-07
- Location
- Redmond, WA
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