Events

Alerte De Sécurité sur Trade name: ADVIA CENTAUR CA 19-9 Technical name: ANTIGEN CA 19-9 Registration number ANVISA: 10345161747 Hazard class: III Affected model: Kit for 50 tests; 250 test kit Serial numbers affected: 94990382, 39741386, 51303388, 82030380, 86322380, 6712382, 39742386, 48671388, 51673388, 60175390, 33687386, 80293380, 87147380

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
    2083
  • Date
    2016-11-18
  • 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
    For clients who use the CA 19-9 trial in the ADVIA Centaur CP and ADVIA Centaur / XP / XPT systems alternately, a review of patient outcomes generated over the past three months is recommended. Customers should not use the ADVIA Centaur XP / XPT and ADVIA Centaur CP Systems together to generate CA 19-9 results for patient monitoring. Serial patient monitoring can continue as long as the system is used independently.
  • Cause
    The advia centaur cp assay ca 19-9 does not meet the correlation with the ca 19-9 assay of the advia centaur / xp / xpt systems as mentioned in the instructions for use. advia centaur cp generates lower results for patient samples. correlation and bias between systems can be verified in customer notification. with quality control material and external quality assessment material, customers may observe a bias in which the results of the ca 19-9 advia centaur cp test are higher than the results of the ca 19-9 advia centaur / xp / xpt.
  • Action
    Field Action Code CC 16-02 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

Trade name: ADVIA CENTAUR CA 19-9 Technical name: ANTIGEN CA 19-9 Registration number ANVISA: 103...

Manufacturer

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