Events

Recall of PTT-LA

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
    2005-04-05
  • 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-ptt-la-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 April 1, 2005, DIAGNOSTICA STAGO withdrew from the market lot 041755 of the in vitro diagnostic medical device called PTT-LA reference 00599 following the possibility of elongated coagulation times with the freshly reconstituted reagent and / or shortened coagulation time with a reagent stored at 2-8 ° C. after reconstitution. This device is used for the determination of the activated partial thromboplastin time (TCA) sensitized for the detection of lupus anticoagulants (anti-phospholipid antibodies encountered in lupus) .. The company has directly notified the recipients of the offending lot by means of the message attached (01/04/2005) (107 KB) validated by Afssaps. The competent European authorities concerned are informed by 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

PTT-LA
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DIAGNOSTICA STAGO

Manufacturer

DIAGNOSTICA STAGO
  • Source
    LAANSM