Events

Alerte De Sécurité sur Immulite 2000 Immunoassay System, registration 10345161777 ///// Immulite 1000 System, registration 10345160643 /// Immulite 2000 System, registration 10345160645 /// Immulite Immunoassay System 10345161653. The identification of the affected products are listed in the Chart in Attachment.

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 Inc..

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
    1636
  • Date
    2015-07-10
  • 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 the holder due to the problem in the conductive material, measurement errors may occur at the level even though there is the minimum volume of sample present in the sample cup or tube. . An error message may appear if there is not enough sample in the microsample tube or sample cup
  • Cause
    The conductive material of the immulite / immulite 1000 sample cup holders and the immulite 2000 / immulite 2000xpi microsample inserts, both used for sample processing, do not meet the specification to facilitate measurement of the liquid and sample level respectively (sensor error). level).
  • Action
    According to the holder of the registration, for IMMULITE / IMMULITE 1000 the problem can be solved by adding more sample to the sample cup. For IMMULITE 2000 / IMMULITE 2000XPi the problem can be solved by adding more sample to the micro-sample tube. The company will make a field correction of the analyzers with replacement of the units. See affected lots in the ANNEX. Upon receiving the new sample cup Holder or microsample insert discard the products from the problematic lots.

Device

Immulite 2000 Immunoassay System, registration 10345161777 ///// Immulite 1000 System, registrati...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Inc.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA