Events

Recall of STAPHYTECT PLUS

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 OXOID.

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
    2003-09-09
  • 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-3-lots-du-dmdiv-staphytect-plus-de-par-la-societe-oxoid
  • 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 company OXOID withdraws from the market lots 288005 (per.28.02.04); 293832 (per.30.04.04) and 300154 (per.30.06.04) of the in vitro diagnostic medical device called STAPHYTECT PLUS - reference DR0850M, following a stability problem that could lead to false positive results. This device is an on-card latex agglutination test, which makes it possible to differentiate between Staphylococcus aureus possessing the clumping factor, protein A and capsular polysaccharides specific for the metastoresistant strains (MRSA) of other staphylococci which do not possess them.

Device

STAPHYTECT PLUS
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    OXOID

Manufacturer

OXOID
  • Source
    LAANSM