Z-2398-2012Class II

The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a...

Name: Z-2398-2012 The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a...
Creator: Bio-Rad Laboratories
Published: 2012-07-27
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2012-07-27 / Terminated / root cause: packaging

FDA source

Bio-Rad Laboratories began a recall of 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... on 2012-07-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2398-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-27
Posted: 2012-09-17
Terminated: 2012-12-14
Recalling firm: Bio-Rad Laboratories Inc.
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.
Product code: LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 7,400 (approximately)- All lots since distribution date May 9, 2007
Distribution: Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe.
Product codes and lots: All lots distributed from May 5, 2007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2398-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2398-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-17

Product code LOM

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)