Events

Recall of Nichols Advantage® ACTH

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 DPC France.

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
    2005-05-30
  • 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-immulite-ace-dpc-france
  • 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 May 27, 2005, the company DPC France withdrew from the market lots 302 and 303 (per 31/08/05) in vitro diagnostic medical device called Immulite ACE reference LKCE1 following the detection of a defect in stability on these lots resulting in a significant decrease in the slope of the adjustments and, not systematically, in control values ​​outside the indicated areas. This device is used for quantitative determination of carcinoembryonic antigen (CEA) in serum, with the analyzer Immulite. This test is an aid in the follow-up of the cancers and in the establishment of a prognosis. The company directly warned the recipients of the incriminated lots by means of the attached message (27/05/2005) (10 ko) validated by AFSSaPS. The relevant European Competent Authorities 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 medical services. concerned.

Device

Nichols Advantage® ACTH
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DPC France

Manufacturer

DPC France
  • Source
    LAANSM