Events

Recall of 4% BioVue Top

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 ORTHO CLINICAL DIAGNOSTICS.

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
    2004-05-12
  • 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-4-biovue-top-de-par-ortho-clinical-diagnostics
  • 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
    Ortho Clinical Diagnostics withdraws lot 417 (per 27.05.04) from the market for in vitro diagnostic medical device called 4% BioVue Top / panel of untreated red blood cells and red cells treated with papain for the identification of irregular antibodies - reference 707790, following the detection, during post-release controls, of possible haemolysis in the vials containing papainous red blood cells. This device is a panel of ready-to-use human red blood cells, for the identification - in human serum or plasma - of irregular antibodies directed against erythrocyte blood group antigens on the Ortho BioVue system, using enzymatic and non-enzymatic techniques.

Device

4% BioVue Top

Manufacturer

ORTHO CLINICAL DIAGNOSTICS