Events

Alerte De Sécurité sur CORTISOL IMMULITE, Kit for 100 tests, Registration 10345160665, lots 381, 382 and 383

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 Ltd.

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
    1442
  • Date
    2014-10-17
  • 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
    The overseas manufacturer performed the problem analysis, evaluating all the inherent risks that generated the corrective action in the field. Based on the investigation and mitigation of the risk conducted, this action was classified as without health risk, its severity being low and its probability of occurrence unlikely. The positive bias observed in cortisol values ​​may potentially lead to further investigation of the status of the adrenal gland. The overall health risk is negligible. Siemens does not recommend a previous review of the results for this reason.
  • Cause
    Siemens healthcare diagnostics has confirmed that the immulite / immulite 1000 cortisol kits 381, 382 and 383 demonstrate a positive bias with patient samples in the range of approximately 13% to 40%. positive bias has also been observed in quality control materials and may result in values ​​outside the stated ranges.
  • Action
    The company advises customers to stop using the product, segregate any remaining stock from the affected lots of CORTISOL IMMULITE with the intention of returning these products to Siemens and to keep the letter with the laboratory records.

Device

CORTISOL IMMULITE, Kit for 100 tests, Registration 10345160665, lots 381, 382 and 383

Manufacturer

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