Events

Recall of Vitros Immunodiagnostic Products / IgM anti-VHA standard

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
    2000-05-23
  • 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-de-reactif-denomme-vitros-immunodiagnostic-products-etalon-igm-anti-vha
  • 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
    Lot 60 of the reagent called Vitros Immunodiagnostic Products / IgM anti-VHA standard (reference 1372101) from the company ORTHO CLINICAL DIAGNOSTICS is withdrawn from the market due to a risk of lowering the signal that may cause a rise in the values ​​of the controls beyond the specifications and elevation of values ​​of patient samples. As a result, from the date of expiration of the calibration curve that has been validated by control values ​​in accordance with those expected after use of the standard control protocol, lot 60 of the reagent called Vitros Immunodiagnostic Products / cartridge IgM anti-HAV reagent (reference 8450124), mandatory for use with the former, is also withdrawn from the market.

Device

Vitros Immunodiagnostic Products / IgM anti-VHA standard

Manufacturer

ORTHO CLINICAL DIAGNOSTICS