Events

Recall of Stratus CS MYO DILPAK ;Stratus CS CKMB DILPAK;Stratus CS TROP DILPAK- code CCTNI-D

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
    2000-08-03
  • 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-de-reactifs-denommes-stratus-cs-myo-dilpak-code-cmyo-d-stratus-cs-ckmb-dilpak-code-cckmb-d-stratus-cs-trop
  • 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
    Lots 810013002 (per.08.12.2000), 819263002 (per.15.08.2000), 810094002 (per.28.02.2001) of the reagent called Stratus CS MYO DILPAK - code CMYO-D 840073002 (per.13.03.2001), 840151002 (per30.05.2001) the reagent called Stratus CS CKMB DILPAK- code CCKMB-D; 830073002 (per.13.03.2001), 830115002 (per.02.04.2001), 830151002 (per.28.11.2000) of the reagent called Stratus CS TROP DILPAK- code CCTNI-D of the company DADE BEHRING SA are withdrawn from the market following a problem with the Stratus CS analyzer version 1.2.1 software when rendering the results for the automatically diluted heparin plasma samples. As a precaution, to avoid the possibility of erroneous results, was decided to block the automatic dilution function by removing the dilution reagent dedicated to this analyzer.

Device

Stratus CS MYO DILPAK ;Stratus CS CKMB DILPAK;Stratus CS TROP DILPAK- code CCTNI-D
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING SA

Manufacturer

DADE BEHRING SA
  • Source
    LAANSM