Events

Recall of DRUGCHECK

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 ALL DIAG.

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
    2005-07-04
  • 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-drugcheck-10-all-diag
  • 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 June 30, 2005, the company ALL DIAG withdrew from the market the batch DOA5030060 of the in vitro diagnostic medical device called DRUGCHECK reference 5456. This decision follows the detection of non-compliant labeling on the cassettes. Indeed, the sequence of the various narcotics recorded on the tape is wrong, resulting in a possibility of rendering a false positive result for a given narcotic and falsely negative for a second .. This device is a rapid test of simultaneous detection of a panel of The company has directly notified the recipients of the offending batch by means of the attached message (30/06/2005) (12 KB) validated by Afssaps. The competent authorities concerned is informed by Afssaps. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

DRUGCHECK
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    ALL DIAG

Manufacturer

ALL DIAG
  • Manufacturer Parent Company (2017)
    Biosynex
  • Source
    LAANSM