Events

Recall of OPUS Troponin I (cTn) Modules-Test

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 DADE BEHRING.

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
    2003-10-14
  • 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-opus-troponine-i-ctn-ref--oqvy-de-par-dade-behring
  • 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 company Dade behring withdraws from the market the batch CTL7 (per.05.05.04) of the in vitro diagnostic medical device called OPUS Troponin I (cTn) Modules-Test - reference OQVY, following the possibility of absence of the conjugate solution for a small number of test modules resulting in the appearance of an error message (LLC, NSIG or BLWL) on the OPUS PLUS PLCs and the appearance of an error message (NSIG or BLWL) or possibly an erroneous, plausible result appears on OPUS PLCs. This device allows the determination of cardiac troponin I in serum and heparinized plasma, on OPUS and OPUS PLUS systems.

Device

OPUS Troponin I (cTn) Modules-Test
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING

Manufacturer

DADE BEHRING
  • Source
    LAANSM