Events

Recall of Flex® C-Reactive High Sensitivity Protein Cartridge (RCRP)

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
    2005-06-09
  • 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-cartouche-de-reactifs-flex-r-rcrp-dade-behring2
  • 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 June 6, 2005, Dade Behring removed the lots from the market. CF5285 (12/10/2005). EJ5294 (21/10/2005). EG5300 (per 27/10/2005). CJ5336 (02/12/2005). EF5306 (02/11/2005). BP5316 (12/11/2005). BA5326 (02/11/2005). DH5341 (07/12/2005). DE5348 (14/12/2005). FJ5356 (22/12/2005) ,. of in vitro diagnostic medical device called Flex® C-Reactive High Sensitivity Protein Cartridge (RCRP) reference DF34 .. This decision follows the identification of a stability problem with the consequence of an inability to calibrate the method, either results with error messages, or imprecision or random accuracy of patient results and quality controls. This device is used for the quantitative determination of C-reactive protein in serum and heparinized plasma. on the Dimension® clinical chemistry system .. The company has directly notified the recipients of the offending lots by means of the enclosed message (06/06/2005) (13 KB) validated by Afssaps. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, directors of health correspondents of reactive vigilance for dissemination, where appropriate, to the services concerned.

Device

Flex® C-Reactive High Sensitivity Protein Cartridge (RCRP)
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING

Manufacturer

DADE BEHRING
  • Source
    LAANSM