Events

Recall of Synchron Systems reagent gamma-glutamyltransferase (GGT)

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 BECKMAN COULTER.

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
    2004-11-24
  • 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-synchron-systems-reactif-ggt-de-beckman-coulter
  • 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 November 23, 2004, Beckman Coulter withdrew from the market lot T402274 (expiry 31/05/05) of reference 476846 of the in vitro diagnostic medical device called Synchron Systems reagent gamma-glutamyltransferase (GGT) following results Quality control out of limits on the low level and overvalued patient results. This information is intended for health facility directors, laboratory directors and local vigilance correspondents for dissemination, where appropriate, to the services concerned. The competent European authorities concerned shall be informed of this measure by the manufacturer.

Device

Synchron Systems reagent gamma-glutamyltransferase (GGT)
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER