Events

Recall of Scangel Monoclonal ABO / RH

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 BIORAD.

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
    2005-09-02
  • 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-scangel-monoclonal-abo-rh-biorad
  • 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 August 31, 2005, BIORAD removed from the market the serial numbers between 11500 and 71000 of batch 5003901 of the in vitro diagnostic medical device called Scangel Monoclonal ABO / RH reference 86426. This decision follows the identification of a weak (+ to +) non-specific reaction in the anti-A well. This device is a test intended for carrying out the ABO globular test and for determining the RH1 (D) antigen. It combines the principles of agglutination and gel filtration .. The company has directly notified the recipients of the offending batch by means of the attached message (31/08/2005) (59 KB) validated by Afssaps. The European Competent 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

Scangel Monoclonal ABO / RH
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIORAD

Manufacturer

BIORAD
  • Source
    LAANSM