Events

Alerte De Sécurité sur IMMULITE / IMMULITE 1000 Osteocalcin, Registration nº 10345161079 - Lots 316, 317 and 319.

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..

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
    1383
  • Date
    2014-05-02
  • 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 company reports that, based on research conducted, Osteocalcin may serve as a measure of increased bone resorption in some patients. Depending on the treatment approach, osteocalcin dosing may be correlated with therapy. In some patients the risk of osteoporosis correlates with increased osteocalcin values. Low recovery of osteocalcin is not expected to impact treatment.
  • Cause
    Siemens has confirmed an average low 50% recovery in patient values ​​over the entire reported range of the immulite / immulite 1000 osteocalcin (lkon1) test in the lots listed above, and the bias may not be detected by the quality control material.
  • Action
    The company informs that customers were instructed to discontinue use of affected lots; to segregate remaining units in their inventories to collect them; discuss the alert message with the person in charge of the laboratory in order to evaluate the need to review previously released results; to complete the effectiveness verification form and to keep the letter filed with the laboratory records. For more information, see Annex I - Customer Letter.

Device

IMMULITE / IMMULITE 1000 Osteocalcin, Registration nº 10345161079 - Lots 316, 317 and 319.

Manufacturer

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