Events

Recall of Flex reagent cartridge CKMB Mass (MMB)

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
    2006-04-04
  • 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-reactif-flex-ckmb-masse-mmb-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
    On April 3, 2006, the company Dade Behring withdrew from the market batches DE6347 (per 13/12/2006) and CG7003 (per 03/01/2007) of the in vitro diagnostic medical device called Flex reagent cartridge CKMB Mass (MMB) reference RF420. This device is a test to quantitatively measure the creatine kinase MB (CKMB) isoenzyme in human serum and plasma on the Dimension clinical chemistry system. This measure is motivated by quality control results that may have a negative bias of 19% to 45% and checks on patient samples have shown a negative bias of 15% to 25% that can occur with quality controls located in the expected values. The company has directly notified the recipients of the offending batches by means of the attached message (03/04/2006) (17 KB) validated by Afssaps. This information is intended for laboratory managers, the directors of health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

Flex reagent cartridge CKMB Mass (MMB)
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING

Manufacturer

DADE BEHRING
  • Source
    LAANSM