Events

Alerte De Sécurité sur Enzygnost® Anti-VZV / IgG - Registration number: 10345161685 - Risk class II (Products of medium risk to the individual and / or low risk to public health, subject to registration) - Lots: 44218; 44309; 44565; 45077.

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 Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

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
    1695
  • Date
    2015-10-22
  • 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
    The company recommends discontinuing the use of the Enzygnost Anti-VZV / IgG product.
  • Cause
    Lots 44309; 44565; 45077 of the enzygnost anti-vzv / igg product may exhibit a greater variation of homogeneity. this can lead to invalid races because they do not meet the p / n reference validation criteria at the beginning and end of the series. this issue may lead to an underestimation of the immunity status measured by the titration levels as the absorbance values ​​of samples with falsely low results. the risk of false negative results is unlikely but can not be totally excluded. when monitoring a potential infection by changing the title level over time with repeated design, the variance of the levels may be higher than expected. in rare cases, this can lead to a title change.
  • Action
    The company that holds the registration is promoting the "Discontinuation of use" of the product. (Attached Letter to Clients). PI Code 15-019.

Device

Enzygnost® Anti-VZV / IgG - Registration number: 10345161685 - Risk class II (Products of medium ...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA