Events

Recall of SIMPLASTIN;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
    2005-08-16
  • 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-et-information-sur-les-reactifs-simplastin-et-simplastin-excel-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
    On August 11, 2005, following the detection of erroneous values ​​of the lndex of Sensibility International (ISI) in the record of these reagents, the company BioMérieux. has withdrawn lot 161711 from the market called SIMPLASTIN EXCEL (reference 252000 (6ml)) (expiry date 09/05). recommended to the users of the 19 batches of SIMPLASTIN EXCEL and SIMPLASTIN EXCEL S reagents mentioned in the attached mail, to take into account the new ISI values ​​redetermined for each batch of reagent / PLC, by the company BioMérieux, in order to calculate the International Normalized Ratio (INR) .. These devices are used for the determination of the Quick Time in human plasma. The time of Quick makes it possible to detect the abnormalities of the coagulation. The company directly warned the recipients of the incriminated batches by means of the attached message (11/08/2005) (30 ko) validated by the Afssaps. The European Competent Authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and health-vigilance correspondents for dissemination, where appropriate, to the departments concerned. (26/08/2005) (16 KB) sent by the laboratory. The mail from the laboratory was modified on August 26, 2005: an error occurred in the mail of August 16, 2005, Ref: MTK / em - 078 Table A page 2 and Acknowledgment page 5.

Device

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

Manufacturer

BIOMERIEUX