Events

Recall of STA® Liatest® D-Di

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
    2005-10-10
  • 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-d-un-lot-du-dmdiv-sta-r-liatest-r-d-di-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 October 06, 2005, Diagnostica Stago withdrew from the market lot 050625 of the in vitro diagnostic medical device called STA® Liatest® D-Di reference 00515 following the demonstration of an unusually low reactivity for this lot. However, this batch still conforms to the expected analytical performance. This is a precautionary measure considering the potential loss of reactivity over time. This device is used for the quantitative determination of D-Dimer on STA® line devices by immuno-turbidimetric method. The company has directly notified the recipients of the offending batch by means of the attached message (06/10/2005) (57 KB) validated by the Afssaps. This information is intended for laboratory managers, directors of establishments of health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

STA® Liatest® D-Di
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Diagnostica Stago

Manufacturer

Diagnostica Stago