FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories: Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.
- Recall number
- Z-1189-2008
- Recalling firm
- Bio-Rad Laboratories
- Product
- Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.
- Status
- Terminated
- Initiated
- 2008-01-07
- Posted
- 2008-08-20
- Terminated
- 2011-03-07
- Reason
- 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
- 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
- 31 distributed
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot Number 232BGG
- 510(k) numbers
- not on file
- PMA numbers
- ["P060031"]
- Product code
- not on file
- Firm FEI
- 3008272466
- Firm city
- Redmond
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28