Recall of Slidex Rota-Kit 2

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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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 31 March 2006, bioMérieux withdrew from the market batches 50608 B (per 10/08/2006), 50608 C (per 10/08/2006), 50609 (per 10/08/2006) and 60165 21/02/2007) of the in vitro diagnostic medical device called Slidex Rota-Kit 2, reference 58842. This device is a rapid card agglutination test of latex particles for the qualitative detection of rotavirus in human stool. . This measure follows the identification of a decrease in sensitivity that could lead to false negative results. The company has directly notified the recipients of the offending lots by means of the attached message (04/04/2006) (25 KB) validated by Afssaps. The relevant European competent authorities are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.


  • Model / Serial
  • Product Description
  • Manufacturer