Events

Recall of VITROS® CRBM Analytical Plates

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
    2005-06-06
  • 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-dmdiv-plaques-analytiques-vitros-r-crbm-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 June 2, 2005, Ortho Clinical Diagnostics removed from the market all generations 18, 19, 20, 21 and 23 batches of the in vitro diagnostic medical device called VITROS® CRBM Analytical Plates, reference 889 2382 following the falsely high results. This device is used for the quantitative determination of the concentration of carbamazepine (CRBM) in serum and plasma. The company has directly notified the recipients of the offending lots by means of the message attached (02/06/2005) (38 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

VITROS® CRBM Analytical Plates

Manufacturer

ORTHO CLINICAL DIAGNOSTICS