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
    2005-03-23
  • 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-r-top-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
    On March 18, 2005, Ortho-Clinical Diagnostics withdrew lot 509 (April 07, 2005 expiry) from the in vitro diagnostic medical device called 4% BioVue® Top, reference 707790, following the detection of red blood cells. present in the papain flask n. 6 and papain flask, antigens not conforming to the antigens appearing on the antigenic profile "Antigram" present in each of the boxes. This device is used for the identification of anti-erythrocyte antibodies in serum or plasma. The company has directly notified the recipients of the incriminated lot by means of the attached message (18/03/2005) (176 KB). The relevant European Competent Authorities 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

4% BioVue® Top

Manufacturer

Ortho-Clinical Diagnostics