Events

Recall of SAFETY-TEST ABO

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 DIAGAST.

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
    2000-12-08
  • 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-lot-d-un-reactif-denomme-safety-test-abo
  • 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    The lots 002000, 003000, 004000 of the reagent called SAFETY-TEST ABO / reference 79059 of the company DIAGAST are withdrawn from the market following the presence of PTU-AB card / reference 79054, batch 032000 among their constituents; this batch 032000 having been withdrawn on December 7, 2000.

Device

SAFETY-TEST ABO
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DIAGAST

Manufacturer

DIAGAST