Events

Recall of ACCESS CK-MB Calibrators

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
    2002-03-14
  • 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-reactif-access-ck-mb-calibrators-de-la-societe-beckmann-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
    The company Beckman Coulter withdraws from the market lot 193027 (per 15.07.02) of the in vitro diagnostic medical device called: ACCESS CK-MB Calibrators - ref. 33335, due to the possibility of incorrect assignment of the target value of the S1 calibrator on certain batch sheets (3.1 ng / ml instead of 2.8 ng / ml), resulting in a failure of the assay linked to the obtaining of results of out-of-specification quality controls. This reagent provides the calibration necessary for the determination of the creatine kinase CK-MB isoenzyme on ACCESS; dosing performed mainly in the diagnosis and follow-up of myocardial accidents.

Device

ACCESS CK-MB Calibrators
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER