Events

Recall of Microtrak II Chlamydia EIA

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 DADE BEHRING SA.

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
    2000-02-15
  • 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-reactif-denomme-microtrak-ii-chlamydia-eia
  • 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
    Lot G22512 of the reagent called Microtrak II Chlamydia EIA - reference 8H709 of the company DADE BEHRING SA is withdrawn from the market following a possible invalidation of the controls in 3% of the kits, resulting in invalidation of the results.

Device

Microtrak II Chlamydia EIA
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING SA

Manufacturer

DADE BEHRING SA
  • Source
    LAANSM