Events

Recall of SIMPLASTIN EXCEL

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 BIOMERIEUX.

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
    2003-02-07
  • 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-dispositif-simplastin-excel-de-la-societe-biomerieux
  • 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 BIOMERIEUX company withdraws from the market lots161432 (per.04.03); 161447 (per.07.03); 161448 (per.09.03); 161479 (per.10.03); 161507 (per.06.03); 161508 (per.02.04); 161595 (per.02.05); 161657 (per.03.05) and 161658 (per.04.05) of the in vitro diagnostic medical device called: SIMPLASTIN EXCEL - reference 252000, due to their heterogeneity leading to abnormally long Quick * (TQ) times from some vials. Therefore, if the TQ of the test plasma is made using a different vial than the one used to determine the Control TQ, the calculation of the INR (International Standardized Report) may be overestimated (elevation greater than 0.3) and lead to a misinterpretation. * The time of Quick (TQ) explores all the factors of the extrinsic pathway of coagulation.

Device

SIMPLASTIN EXCEL
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX