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
    2003-01-29
  • 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-rectif-simplastin-excel-s-reference-252183-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
    BIOMERIEUX withdraws from the market lot 161662 (expiry date 10/2004) following the possibility, with certain bottles of the lot concerned, of obtaining an abnormally extended Quick time for normal times (from 3 to 4 seconds) and the risk of overestimation of INR (International Standardized Ratio) if the vial used to determine the control's Quick Time is not the same as that used for the patient. This withdrawal follows the investigations that were conducted by BIOMERIEUX after the recall of lots 161553, 161581 and 161661 of SIMPLASTIN EXCEL S - reference 252182 (10 X 6 ml) carried out on 27/12/02, for the same reasons. Quick is part of the coagulation exploration tests.

Device

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

Manufacturer

BIOMERIEUX