Events

Alerte De Sécurité sur PSA Third Generation IMMULITE® / IMMULITE® 1000 - Registration 10345160987. Lots: 320 and 321.

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 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
    1291
  • Date
    2013-09-03
  • 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 analysis identified that the severity is insignificant, because as the controls of the assay are out of range, adjustment will occur, preventing the release of patient results. There is no impact to patient samples when values ​​are not reported, so this action is classified as without health risk. Letter to the client: http://portal.anvisa.gov.br/wps/wcm/connect/6c0ba8804115b1d2aed3af0ea338d2ac/Carta_aos_clientes_+IMC_13_20.pdf?MOD=AJPERES
  • Cause
    Adjustment faults with the 3rd generation immulite® / immulite® 1000 psa kits (lkup1) of batches 320 and 321. some kits may contain committed (lupl / h) patch paths of lot 0126, which may lead to adjustment faults and / or exceed the established interval. if the adjustment is correct, the quality control results within the established range, the kit can be used to release patient results.
  • Action
    Customers were instructed to discontinue use of the product, segregate any remaining stock from the affected lot of the Third Generation IMMULITE® / IMMULITE® 1000 PSA in order to return these products to Siemens and keep the letter with the laboratory records.

Device

PSA Third Generation IMMULITE® / IMMULITE® 1000 - Registration 10345160987. Lots: 320 and 321.

Manufacturer

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