Events

Rappel de Siemens Advia Liquid Specific Protein (LSP) Calibrator

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Siemens Healthcare Diagnostics Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    17675
  • Date de mise en oeuvre de l'événement
    2014-11-12
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 recall data from the U.S. and New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Cause
    Siemens healthcare diagnostics has confirmed two issues with the siemens liquid specific protein (lsp) calibrator lot 303574:, issue 1: siemens has observed an increased frequency of max fit deviation flags using the liquid specific protein (lsp) calibrator kit lot 303574 (vial lots 122it - 127it) to calibrate the alpha-1-antitrypsin (aat) assay., issue 2: siemens has confirmed that a preliminary version of the liquid specific protein (lsp) calibrator lot-specific instructions for use (ifu) for calibrator kit lot 303574 resided on the siemens document library from december 10, 2013 until april 7, 2014. the lsp calibrator ifu version that resided on the siemens document library during this time contained preliminary calibrator values that differed slightly from the final calibrator values for the following advia chemistry systems assays: aag, aat, aso_2, c3, c4, frt, hapt, iga_2, igg_2, igm_2, prealb, rf and trf.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens Advia Liquid Specific Protein (LSP) Calibrator

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    NZMMDSA