Events

Recall of Plasma free of factor VIII coagulation

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
    2005-07-18
  • 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-plasma-exempt-de-facteur-viii-de-la-coagulation-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 July 13, 2005, the company Dade-Behring removed from the market batches 503846A, 503850C and 503853A of the in vitro diagnostic medical device called Plasma free of factor VIII coagulation reference OTXW. In addition, batches 503847D, 503849D, 503849E, 503856B, 503856C, 503857A, 503858A, 503848A, 503859B, 503860D and 536501 of this same device are the subject of recommendations for use. This device is used when assaying coagulation factor VIII activity in human plasma by coagulometric methods. These decisions stem from the possibility of falsely elevated patient outcomes that may lead to misdiagnosis of the severity of hemophilia A or the inability to accurately track substitution therapy. The company has directly notified recipients incriminated lots by means of the attached message validated (13/07/2005) (104 ko) by the Afssaps. The competent European authorities concerned are informed directly by the manufacturer. This information is intended for those responsible for laboratory, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Plasma free of factor VIII coagulation
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Dade-Behring

Manufacturer

Dade-Behring
  • Source
    LAANSM