Events

Recall of STREPTOP A

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
    2002-12-24
  • 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-dispositif-streptop-a-reference-5443-par-la-societe-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 6 December 2002, ALL-DIAG withdrew from the market STA 20202 (per 02/2004) the in vitro diagnostic medical device called STREPTOP A - reference 5443, following a stability problem on certain test strips that could lead to , after a storage period of five months, the appearance of false positive results. ALL-Diag directly informed the 107 laboratories of medical analyzes concerned by this batch of device used for the research of Streptococcus A.

Device

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

Manufacturer

ALL-DIAG
  • Source
    LAANSM