Events

Recall of Slidex Strepto-Kit

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
    2006-03-06
  • 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-des-dmdiv-slidex-strepto-kit-slidex-strepto-b-et-slidex-strepto-d-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 March 2, 2006, bioMérieux removed from the market In Vitro Medical Diagnostic Devices called:. Slidex Strepto-Kit - reference 58810 - lots 50822 (per 30/08/2006), B 50822 (per 30/08/2006), 50924 (per 04/10/2006). Slidex Strepto B - reference 58816 - lots 50913 (per 08/09/2006), 51035 (per 07/11/2006). Slidex Strepto D - reference 58817 - lots 50920 (06/10/2006) .. These devices are latex particle agglutination tests for rapid grouping of beta-hemolytic streptococci A, B, C, D, F and Lancefield's G .. This measure follows the discovery of a decrease in the sensitivity of the latexes that may be at the origin of non-identification of a group B, D or F beta-hemolytic streptococcus. The company has directly notified the recipients of the offending lots by means of the enclosed message (01/03/2006) (15 KB) validated by Afssaps. The competent European authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Slidex Strepto-Kit
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX