Events

Recall of Calibrant Urinary Protein

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
    2006-04-13
  • 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-calibrant-proteines-urinaires-beckman-coulter-france
  • 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 11, 2006, Beckman Coulter France withdrew from the market lot M411138 (31/08/2006) of the in vitro diagnostic medical device called Calibrant Urinary Protein reference 441470 following the detection of an instability of the analyte alpha 1 microglobulin may be the cause, after calibration, an overestimation on the parameter alpha 1 microglobulin results of quality control and patient samples. This calibrator is used on the IMMAGE and ARRAY systems. The company has directly notified the recipients of the offending batch by means of the attached message (11/04/2006) (72 KB) validated by Afssaps. This information is intended for laboratory managers, the directors of establishments health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

Calibrant Urinary Protein
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER