Events

Recall of MICROMAT II Hemoglobin A1c tests cartridge

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by BIO - RAD.

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
  • Date
    2002-06-25
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-du-reactif-micromat-ii-hemoglobin-a1c-tests-cartridge-de-la-societe-bio-rad
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Extra notes in the data
  • Action
    The company BIO - RAD withdraws from the market the lots 050K31 (per.31 / 07/02), 050K33 (per.23 / 07/02), 050K37 (per.19 / 09/02), 050K38 (per 01/10 / 02), 050K39 (per.05 / 10/02) of the reagent called MICROMAT II Hemoglobin A1c tests cartridge reference 280-0008 following premature degradation caused by a problem of storage temperature resulting in obtaining assay results of This reagent is used for the determination of hemoglobin A1c in capillary blood or whole blood taken from heparin or EDTA on the BIO-RAD MICROMAT II.

Device

MICROMAT II Hemoglobin A1c tests cartridge
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIO - RAD

Manufacturer

BIO - RAD
  • Source
    LAANSM