Events

Alerte De Sécurité sur Technical Name: PARAMETERS COMBINED ON THE SAME PRODUCT - CLASS II ANVISA Registration Number: 10345160165 Hazard Class: II Affected Model: Commercial presentations of 2 vials of high calibrator and low calibrator (Calibrator A) Advia Centaur, ACS: 180 Systems 5.0mL / unit) and 6 bottles of high calibrator and low calibrator (5.0mL / unit). Serial numbers affected: 07996A90; 21172A90; 27221A90; 43871A90; 44366A90

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
    2169
  • Date
    2017-02-09
  • 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
    Customers using the FT4 assay on the ADVIA Centaur, ADVIA Centaur XP & ADVIA Centaur XPT systems should discontinue use of the field affected lots for the FT4 assay. For the performance of this test, batch calibrators of numbering greater than the affected lot should be used. Customers can continue to use the affected Calibrator A batches for the Free T3 (FT3), Total T3 (T3), Total T4 (T4) and T uptake (Tup) assays for the ADVIA Centaur systems. Customers using the FT4 assay on the ADVIA Centaur CP system can continue to use all available Calibrator A batches. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Cause
    Siemens healthcare diagnostics has confirmed a negative bias for advia centaur free t4 (ft4) when using the a calibrator lots listed above on the advia centaur, advia centaur xp and advia centaur xpt systems. in addition, siemens healthcare diagnostics has confirmed a potential for calibration failures due to the% cvs of the calibrator rlus above the limit when using the calibrator a lots quoted above with the free t4 (ft4) assay. the performance of the free t4 assay (ft4) is not affected when the affected batches of the calibrator are used in the advia centaur cp system.
  • Action
    Field Action Code CC 17-04 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make letter to the client.

Device

Technical Name: PARAMETERS COMBINED ON THE SAME PRODUCT - CLASS II ANVISA Registration Number: 10...

Manufacturer

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