Events

Rappel de ADVIA 1200 CHEMISTRY SYSTEM - LIQUID SPECIFIC PROTEIN CALIBRATORS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SIEMENS HEALTHCARE LIMITED.

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
    78920
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-11-06
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Siemens health care diagnostics has confirmed two issues with the siemens liquid specific protein calibrator lot 303574. issue 1: 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 (att) assay. the max fit deviation flag impacts the level 2 calibrator (123it) for the advia chemistry systems aat assay. issue 2: siemens confirmed that the preliminary version of the siemens lsp calibrator lot-specific instructions for use (ifu) for calibrator kit lot 303574 resided in the siemens document library from dec.10 2013 until apr.07 2014. the lsp calibrator preliminary factor values during this time differed slightly from the final factor values for the following advia chemistry stystem assays: aag aat aso_2 c3 c4 frt hapt iga_2 igg_2 igm_2 prealb rf and trf. the ifu insert packaged in the siemens lsp calibrator kit lot 303574 always contained the correct values for all those assays except aat. the ifu that is currently in the kit and the ifu that was in the siemens document library from apr.07 2014 to oct.30 2014 does not reflect the updated aat calibrator value for lsp calibrator level 2. as of oct.31 2014 all of the final lsp calibrator values are correct on the siemens document library. when using either the final or preliminary calibrator values quality control results recover well within the manufacturer's specified upper and lower ranges and patient sample results did not demonstrate clinically significant differences.

Device

ADVIA 1200 CHEMISTRY SYSTEM - LIQUID SPECIFIC PROTEIN CALIBRATORS
  • Modèle / numéro de série
    Model Catalog: 07711199 (Lot serial: 303574)
  • Description du dispositif
    ADVIA 1200 Chemistry System - Liquid Specific Protein Calibrator
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HC