Events

Rappel de Liquid Specific Protein (LSP) Calibrator

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Ltd Diagnostics Division.

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
    RC-2014-RN-01204-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-11-13
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01204-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    - siemens has observed an increased frequency of max fit deviation flags using the lsp calibrator kit lot 303574 (vial lots 122it – 127it) to calibrate the alpha-1-antitrypsin (aat) assay. the max fit deviation flag impacts the level 2 calibrator (123it) for the advia chemistry systems alpha-1-antitrypsin (aat) assay. while there is a potential for delay in alpha-1-antitrypsin results due to calibration failures, the risk to health as a result of this issue is negligible.- the lsp calibrator ifu version that resided on the siemens document library from december 10, 2013 until april 7, 2014contained 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. the differences between either the final or preliminary calibrator values would not affect the utility of these tests in clinical practice.
  • Action
    Siemens is providing laboratories with the correct calibrator values.

Device

Liquid Specific Protein (LSP) Calibrator
  • Modèle / numéro de série
    Liquid Specific Protein (LSP) CalibratorCatalogue Number: 07711199Lot Number: 303574Expiry Date: Nov 2015An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA