Z-1189-2008

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

Name: Z-1189-2008 Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic
Creator: Bio-Rad Laboratories
Published: 2008-01-07
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2008-01-07 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories began a recall of Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic on 2008-01-07. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1189-2008
Status: Terminated
Initiated: 2008-01-07
Posted: 2008-08-20
Terminated: 2011-03-07
Recalling firm: Bio-Rad Laboratories Inc.
Product: Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 31 distributed
Distribution: Nationwide Distribution.
Product codes and lots: Lot Number 232BGG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)