Events

Recall of Dade® Actin® FS

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 DADE BEHRING.

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
    2005-10-05
  • 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-de-lots-du-dmdiv-dade-r-actin-r-fs-dade-behring
  • 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 03 October 2005, the company Dade Behring withdrew from the market lot 527263 (03/02/2006) of the reference B4218-100 and the lot 527264 (per 21/01/2006) of the reference B4218-20 of the in vitro diagnostic medical device called Dade® Actin® FS following the demonstration of a performance defect resulting in an increase in activated partial thromboplastin time (aPTT). The company has directly notified the recipients of the offending lots by means of the enclosed message (03/10/2005) (11 KB) validated by Afssaps. The relevant European authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Dade® Actin® FS
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING

Manufacturer

DADE BEHRING
  • Source
    LAANSM