Events

Recall of Rapid ATB STAPH DMDIV

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 BIOMERIEUX.

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
    2006-04-06
  • 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-rapid-atb-staph-biomerieux
  • 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
    On April 5, 2006, the company bioMérieux withdrew from the market lot 795246101 (per 14/06/2006) of the in vitro diagnostic medical device called Rapid ATB STAPH reference 14479. This device is a gallery to determine the sensitivity of Staphylococcus antibiotic aureus within 4h30 to 5h, on the PLC ATB or mini API. This measure follows the demonstration of an insufficient antibiotic load for the combination Quinupristine / Dalfopristine (QDA) that can generate a false-resistant result with this combination of antibiotics. The company has directly notified the recipients of the offending lot by means of the attached message (05/04/2006) (27 KB) validated by Afssaps. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Rapid ATB STAPH DMDIV
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX