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Terminated

Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.

FDA Recall Z-1189-2008 · Posted 2008-08-20

Recalling FirmBio-Rad Laboratories
Recall StatusTerminated
Date Initiated2008-01-07
Date Terminated2011-03-07
Product Quantity31 distributed

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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