Events

Recall of SIMPLASTIN EXCEL S

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
    2002-12-27
  • 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-3-lots-du-reactif-simplastin-excel-s-reference-252182-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 batches 161553 (expiry 11/2003), 161581 (expiry 03/2004) and 161661 (expiry date 08/2004) following the possibility, with some bottles of the batches concerned, of obtaining a time abnormally lengthened for normal time (3 to 4 seconds) and at the risk of overestimation of the INR (normalized international ratio) if the vial used to determine the control's Quick time is not the same as the vial used for the patient.

Device

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

Manufacturer

BIOMERIEUX