Events

Recall of Device Recall MONOLISA ANTIHBs EIA

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Rad Laboratories.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62850
  • Event Risk Class
    Class 2
  • Event Number
    Z-2398-2012
  • Event Initiated Date
    2012-07-27
  • Event Date Posted
    2012-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111868
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
  • 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.
  • 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.

Device

Device Recall MONOLISA ANTIHBs EIA
  • Model / Serial
    All lots distributed from May 5, 2007
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe.
  • 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.
  • Manufacturer
    Bio-Rad Laboratories

Manufacturer

Bio-Rad Laboratories
  • Manufacturer Address
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • Manufacturer Parent Company (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA