Events

Recall of Flex Troponin I cardiac reagent size / 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 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
    2002-10-22
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-du-lot-ce3151-per--31-05-03-du-dm-div-dimension-troponine-i-cardiaque-ref--rf421c-de-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
    DADE BEHRING withdraws CE3151 lot (per 31.05.03) from the market for the in vitro diagnostic medical device called: Flex Troponin I cardiac reagent size / cartridge (CTNI) - reference RF421C, following the risk of obtaining results overexposed exceeding the recommended limit (0.1 ng / ml) for acute coronary syndrome risk stratification. This device is used for the determination of cardiac troponin I in serum and heparinized plasma on the Dimension analyzer.

Device

Flex Troponin I cardiac reagent size / cartridge
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING

Manufacturer

DADE BEHRING
  • Source
    LAANSM