Events

Recall of VITROS CHOL Slides

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
    2001-05-23
  • 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-de-lots-du-reactif-vitros-chol-slides-dosage-cholesterol
  • 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
    The batches 0823-0309-XXXX (resulting from the coating 0309) of the reagent called VITROS CHOL Slides / reference 166 9829 of the company ORTHO CLINICAL DIAGNOSTICS are withdrawn from the market following a manufacturing problem resulting in a possible over-estimation of the results for the samples (patients and quality control) of high concentration (greater than 2.0g / l or 5.2mmol / l). However, in view of a potential stock out, initially, only the kits invalidated by the high quality control are immediately affected by this recall. Kits validated by high level quality control can still be used until they are exchanged.

Device

VITROS CHOL Slides

Manufacturer

ORTHO CLINICAL DIAGNOSTICS