Events

Alerte De Sécurité sur LCx kit Neisseria Gonorrhoeae. Lot: 84075M400

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 Laboratórios do Brasil Ltda..

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
    710
  • Date
    2002-07-25
  • 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
    Abbott Laboratories of Brazil Ltda., Is working to accelerate the replacement of the LCx Neisseria Gonorrhoeae product. Lot: 84075M400. and recommends alternative methods for performing the test.///////NOTE: Clinical studies described in the Technical Manual of the trial, represent a small percentage of patient samples that are close to the test cutoff (<0.80). Based on this data, review of patient outcomes is not recommended because the risk of a low positive test being reported as negative is minimal. Thus with any diagnostic test, the results of the LCx Neisseria Gonorrhoeae kit. Batch: 84075M400 should be interpreted in conjunction with other clinical and laboratory data.
  • Cause
    Studies conducted by abbott laboratories have demonstrated that the analytical sensitivity may be out of the one specified in the package insert as being 10 colony forming units. these studies were based on a panel with sensitivity close to the assay cutoff (<0.80) and may generate a positive-low as negative.
  • Action
    Discontinue use of the LCx Neisseria Gonorrhoeae kit. Lot: 84075M400

Device

LCx kit Neisseria Gonorrhoeae. Lot: 84075M400

Manufacturer

Abbott Laboratórios do Brasil Ltda.
  • Source
    ANVSANVISA