Events

Recall of Pathfinder® Virus Herpes Simplex Types 1 and 2

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 Bio-Rad.

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
    2005-12-02
  • 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-pathfinder-r-virus-herpes-simplex-types-1-et-2-bio-rad
  • 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    On 30/11/2005, the company BIO-RAD has withdrawn lot 930848 from the in vitro diagnostic medical device called Pathfinder® Virus Herpes Simplex Types 1 and 2 reference 25215. This device is used for the direct fluorescence test used to identify and typify herpes simplex virus in direct clinical specimens and cell culture isolates. This follows the finding of a few anti-HSV1 monoclonal antibody vials in this lot. may cause a decrease in fluorescence controls and patient samples .. The company has directly notified the recipients of the offending batch by means of the attached message (30/11/2005) (11 KB) validated by Afssaps. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Pathfinder® Virus Herpes Simplex Types 1 and 2
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad