Events

Alerte De Sécurité sur SLIDEX STAPH KIT. Anvisa registration number: 10158120557. Affected lots: 10051 and 73113.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par BioMerieux Brasil SA..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1025
  • Date
    2010-06-24
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    According to Biomerieux, the company decided to collect batches 73112 and 73113 from the Slidex Staph Kit as a result of a failure in the product release process: the aforementioned lots were released for commercialization in the national territory before the end of the analyzes carried out in the laboratory. quality control of the company. The Technovigilance Unit is following up on this case. #### The company informed UTVIG on 10/27/2010 about the completion of the field action, with collection of the affected units and the presentation of the certificate of destruction of the same.
  • Cause
    Some batches of the product were marketed without the approval of the company's quality control area.
  • Action
    Users of the product should perform the following actions: (1) Verify in their inventory the presence of affected lots; (2) If a product is identified as being at risk, it must be segregated and the manufacturer informed. The company said it had already sent warning letters to its customers, stating the problem. The product is being collected from the market by Biomerieux.

Device

SLIDEX STAPH KIT. Anvisa registration number: 10158120557. Affected lots: 10051 and 73113.

Manufacturer

BioMerieux Brasil SA.