Bio-Rad Laboratories Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.
Brand
Bio-Rad Laboratories
Lot Codes / Batch Numbers
Lot Number 232BGG
Products Sold
Lot Number 232BGG
Bio-Rad Laboratories is recalling Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic. due to Incorrect result: Elevated reactivity with a kit lot 232BGG. Patient samples that are negative for antibodies to anti-HBc could be assigned a positive. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026