Events

Recall of STA® CEPHASCREEN® 4 ml

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
    2006-01-10
  • 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-du-dmdiv-sta-r-cephascreen-r-4-ml-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 January 6, 2006, Diagnostica Stago withdrew lots 050733, 050734 and 043072 from the in vitro diagnostic medical device called STA® CEPHASCREEN® 4 ml, reference 00308. This device is used for the determination of the partial thromboplastin time + activator (TCA) on STA® line devices. This measure follows the detection of unexpected elongations of activated partial thromboplastin time in the pathological zone. The company has directly notified the recipients of the incriminated batches by means of the attached message (06/01/2006) (50 KB) validated by the Afssaps. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

STA® CEPHASCREEN® 4 ml
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Diagnostica Stago

Manufacturer

Diagnostica Stago