Events

Alerte De Sécurité sur ARCHITECT i Septum

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 Abbott Loboratórios do Brasil - Divisão Diagnósticos.

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
    793
  • Date
    2004-08-24
  • 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
    It is important to note that this situation occurred only for the ARCHITECT i TESTOSTERONE Reagent LN 6C28-20 and 6Cc28-25 assay, and was not observed for the other assays of the ARCHITECT line. Currently in Brazil, the ARCHITECT TESTOSTERONA Reagent, is not being marketed. If you have questions about the information contained in this release, please call the Customer Service Center, Tel .: 0800-11-9099.
  • Cause
    The abbott diagnostics division determined that the current architect i septum n ° list: 4d18-01, when used in conjunction with the architect assay. testosterone reagent ln 6c28-20 and 6cc28-25 could generate a contamination. this would be possible because of this contaminant present in the current architect i septum n ° list: 4d18-01, have similar chemical structure and compete with testosterone binding sites. with the new architect i septum n ° list: 4d18-02, this contaminant has been eliminated.
  • Action
    Reconstruction of ARCHITECT i Septum. The new ARCHITECT i Septum N ° List: 4D18-02 is being replaced by the current ARCHITECT i Septum N ° List: 4D18-01, used with all ARCHITECT assays. The new ARCHITECT i Septum N ° List: 4D18-02 can be identified by the white color of the package instead of the actual green color ARCHITECT i Septum List Nr .: 4D18-01.

Device

ARCHITECT i Septum

Manufacturer

Abbott Loboratórios do Brasil - Divisão Diagnósticos
  • Source
    ANVSANVISA