Bio-Rad Laboratories: Medical Device Recall in 2012 - (Recall #: Z-2398-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: July 27, 2012

Date Posted: September 26, 2012

Recall Number: Z-2398-2012

Event ID: 62850

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.

Status: Terminated

Product Quantity: 7,400 (approximately)- All lots since distribution date May 9, 2007

Code Information:

All lots distributed from May 5, 2007

Distribution Pattern:

Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe.

Voluntary or Mandated:

Voluntary: Firm initiated