FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories: The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.
- Recall number
- Z-2398-2012
- Recalling firm
- Bio-Rad Laboratories
- Product
- The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.
- Status
- Terminated
- Initiated
- 2012-07-27
- Posted
- 2012-09-17
- Terminated
- 2012-12-14
- Reason
- Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result.
- Root cause
- Packaging
- Action
- The firm, Bio-Rad Laboratories, Inc., sent an "Important Product Information Bio-Rad MONOLISA Anti-HBs EIA Catalog #25220", letter dated 27 July 2012, to their domestic consignees/customers via FedEx. The International subsidiaries will be notified by e-mail. The consignees/customers were informed of the important storage and handling information regarding the MONOLISA Anti-HBs EIA Conjugate Diluent component . The consignees/customers were instructed to follow the storage and handling instructions as stated in the Package Insert, and compare their laboratories practices to the storage and handling instructions stated by Bio-Rad. Customers who have questions can call Bio Rad Technical Support at 1-800-224-6723, option 2, then option 3.
- Quantity
- 7,400 (approximately)- All lots since distribution date May 9, 2007
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe.
- Lot, serial or model codes
- All lots distributed from May 5, 2007
- 510(k) numbers
- not on file
- PMA numbers
- ["P050048"]
- Product code
- LOM
- 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