Events

Recall of IMMUNO-TROL LOW CELLS

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 BECKMAN COULTER.

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
    2003-09-10
  • 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-du-dmdiv-immuno6trol-low-cells-de-par-beckman-coulter
  • 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 28/08/03, Beckman Coulter withdrew from the market Lot 760911F (Per 05.02.04) of the in vitro diagnostic medical device called IMMUNO-TROL LOW CELLS - reference 66070098 due to a stability problem that could lead to Out-of-specification quality control results. This device is a positive control consisting of a preparation of erythrocytes and stabilized human leukocytes - equivalent to whole blood -, to verify the performance of the reagents and methods of labeling the targeted cells, the lysis of erythrocytes and flow cytometric analysis of the samples.

Device

IMMUNO-TROL LOW CELLS
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER