Events

Recall of AUXACOLOR 2

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
    2003-09-12
  • 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-d-un-lot-du-dmdiv-auxacolor-2-de-par-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 lot 3D0021 (per.15.10.04) of the in vitro diagnostic medical device called AUXACOLOR 2 - reference 56513, following a raw material problem concerning only Adonitol. This defect can lead to falsely positive reactions on the adonitol cup and a difficulty in identifying Candida glabrata and Trichosporon inkin strains. This device is a fungal identification gallery.

Device

AUXACOLOR 2
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad