Events

Recall of STA Deficient VII

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 Diagnostica Stago.

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
    2001-12-13
  • 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-lots-de-sta-deficient-viii-de-diagnostica-stago
  • 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 4 December 2001, the company Diagnostica Stago informed the Agency of a withdrawal of lots 003221 (per 11/2002), 003431 (per 12/2002), 011171 (per 04/2003) and 011722 (Per 06/2003) of the in vitro diagnostic device called: STA Deficient VIII - reference 00725. This recall follows the detection of a defect in stability when the STA PTT A method is instruments of the STA line and Multipurpose application [MPR] (semi-automatic or "manual" method). This defect causes a decrease in coagulation times throughout the stability period during the assay and therefore, consequently, an increase in factor VIII levels. This defect has no impact on the diagnosis of hemophilia and the determination of the severity of the disease.

Device

STA Deficient VII
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Diagnostica Stago

Manufacturer

Diagnostica Stago