Events

Alerte De Sécurité sur Actin® Activated Cephaloplastin Reagent, 2 x 10 ml Pack - Registration 10345161140 - lot 557116

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 Ltda.; 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
    1682
  • Date
    2015-09-01
  • 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
    Siemens confirmed for TTPa: variation greater than 3 seconds in the normal range and / or greater than 15% in the pathological range with the product at validity. It is possible that samples with values ​​close to the medical decision point may present deviations in the ranges: normal up to 4 seconds and pathological up to 33%. The upward trend of aPTT in most cases will be recognized by controls outside the designated range.
  • Cause
    Siemens healthcare diagnostics has confirmed internally that for lot 557116 the values ​​of the controls may be outside the designated ranges. in addition, it was observed that the results of the normal control presented values ​​with a tendency of high. this indicates change of product performance even within the validity.
  • Action
    The company advises you to discontinue use and also discard any and all remaining material from the above-mentioned batch of Dade Actin Activated Cephaloplastin Reagent. This field action has the same content as the action communicated through alert 1569; the company's quality department identified the same problem in this lot, which generated this new field action.

Device

Actin® Activated Cephaloplastin Reagent, 2 x 10 ml Pack - Registration 10345161140 - lot 557116

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products GmbH
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA