Events

Recall of Dimension® / Flex ™ Lipase 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 DADE BEHRING SA.

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
    2000-11-21
  • 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-de-reactif-denomme-dimension-r-cartouche-de-reactifs-flex-lipase
  • 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 GA1205 lot of the reagent called Dimension® / Flex ™ Lipase Reagent Cartridge (LIP) - Ref.DF55A from DADE BEHRING SA is withdrawn from the market due to erroneous results with certain cartridges: lower values ​​of the controls and patient samples.

Device

Dimension® / Flex ™ Lipase Reagent Cartridge
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING SA

Manufacturer

DADE BEHRING SA
  • Source
    LAANSM