Events

Recall of ACE reagent cartridge

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
    2003-12-10
  • 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-vitros-ace-par-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 lot 750 (per 14.01.04) from the market for Vitros Immunodiagnostic Products, an in vitro diagnostic medical device / ACE reagent cartridge - reference 1920115, following possible production by streptavidin-coated wells , a light signal lower than expected, may cause a calibration anomaly or results lower than expected assay .. This device is used on the Vitros ECI analyzer for the determination of carcinoembryonic antigen (ACE) ) in human serum or plasma (EDTA or heparin); assay for the diagnosis and treatment of cancer in patients with this condition associated with varying ACE levels.

Device

ACE reagent cartridge

Manufacturer

ORTHO CLINICAL DIAGNOSTICS