Events

Alerte De Sécurité sur ELISA CRUZI - Lot: 61207 - Reference 35117, Anvisa Registry # 10158120521 Contact the Owner

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 Biomérieux Brasil S/A.

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
    863
  • Date
    2007-04-24
  • 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
    Due to the problem presented, considering that the batch involved, exhibits a profile outside the specifications and can compromise the routine of the customers, the Company decided to stop the commercialization, thus promoting the collection of the batch in question. If you have the listed lot in your inventory, contact your local representative or manufacturer by calling 0800.264848 - option 2. - Department of Scientific Support. ANVISA through the Technovigilance Unit will be following the case, in order to ensure that the health products marketed in Brazil have the safety and efficacy necessary to the good performance of the product. Update: On September 27, 2007, the Company presents the UTVIG, a copy of the certificate of destruction of the kits collected in the market.
  • Cause
    The reagent r3 of the batch in question is showing color change (orange to yellow), ph variation and false positive result.
  • Action
    Block the marketing, Inform the customers the collection of said lot

Device

ELISA CRUZI - Lot: 61207 - Reference 35117, Anvisa Registry # 10158120521 Contact the Owner

Manufacturer

Biomérieux Brasil S/A
  • Source
    ANVSANVISA