Events

Recall of VITROS TP (Total Proteins)

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
    2003-04-07
  • 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-dispositif-medical-de-diagnostic-in-vitro-denomme-vitros-tp-proteines-totales-de-par-la-societe-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 lots 0629 0292 0959 from the market; 0629 0292 1043; 0629 0292 1167; 0629 0292 1245; 0629 0292 1424; 0629 0292 1426 (per 01.04.04) of the in vitro diagnostic medical device called VITROS TP (Total Proteins) - reference 8392292, following the possibility of altering the accuracy of the results - patients and controls - obtained with the 0292 coating contained in these device lots. This device allows the determination of the total proteins, in the serum or in the heparinized plasma, on the Vitros automats.

Device

VITROS TP (Total Proteins)

Manufacturer

ORTHO CLINICAL DIAGNOSTICS