Events

Alerte De Sécurité sur Cal Calibrator A Advia Centaur, ACS: 180 Systems, Kit containing: 2 vials (5.0 mL / vial) of high calibrator; 2 vials (5.0 mL / vial) of low calibrator. Kit containing: 6 vials (5.0 mL / vial) of high gauge; 6 vials (5.0 mL / vial) of low calibrator //// Registration: 10345160165, hazard class II. Affected lots: 40978A84; 41239A84; 41846A84; 44162A84; 47938A84; 51961A86; 53232A86; 55812A86; 95551A87; 07628A87; 18026A87.

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
    1720
  • Date
    2015-10-28
  • 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
    Siemes Healthcare identified that these observed differences would not affect patient diagnosis or monitoring, although failures in 1: 4 and 1: 8 dilution recoveries with Calibrator A could affect T4 accuracy levels above the assay range .
  • Cause
    Siemens healthcare diagnostics proactively conducted a customer notification regarding 1: 4 and 1: 8 manual dilution recovery in the advia centaur t4 assay, used in the advia centaur xp, advia centaur xp, advia centaur xp and advia centaur cp systems. siemens has identified that recovery percentages for dilutions of patient samples 1: 4 (with calibrator a prior to the batches terminated at 84 and 86) and 1: 8 (batches terminated at 84, 86 and 87) are lower than the advia centaur t4 instruction for use. (see attached).
  • Action
    Correction of Instructions for Use The company will: discontinue the use of 1: 8 manual sample dilutions of T4 samples on ADVIA Centaur systems. /// Manual dilutions 1: 2 and 1: 4 can be performed for T4 samples with results above the assay range for Batches of Calibrator A terminated at 87 and above. It was confirmed that these dilutions performed as expected. /// Batches of Calibrator A terminated at 84 and 86 may continue to be used for all other assays requiring Calibrator A, except for dilutions of T4 samples. (SEE ANNEX) .Code of Action: CN CC 15-14.

Device

Cal Calibrator A Advia Centaur, ACS: 180 Systems, Kit containing: 2 vials (5.0 mL / vial) of high...

Manufacturer

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