Events

Rappel de DIMENSION VISTA SYSTEM - MAGNESIUM ASSAY

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
    41441
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-09-24
  • 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 healthcare diagnostics has received customer complaints for the dimension vista magnesium (mg) (k3057 10445158) when using lot 15063ba. the complaints were related to erroneous low results on a small number of reagent wells. data collected from the customer complaints shows that there is the potential for under-recovery on certain wells for quality control (qc) and patient sample results. when this issue occurred the under-recovery ranged from -0.3 mg/dl [0.12 mmol/l] to -1.6 mg/dl [0.66 mmol/l]. the average under-recovery was -1.0 mg/dl [0.41 mmol/l]. this issue is demonstrating a low frequency of occurrence with an estimated one (1) in every 10000 tests that may be affected. siemens internal investigations were unable to reproduce this issue likely due to the low probability of occurrence. a root cause investigation is ongoing. repeating the sample on a new well of reagent or a new flex cartridge resolves the issue. this issue is likely to be detected by quality control (qc) or calibrators if they are run on the affected wells of reagent.

Device

DIMENSION VISTA SYSTEM - MAGNESIUM ASSAY
  • Modèle / numéro de série
    Model Catalog: K3057 (Lot serial: 15063BA)
  • Description du dispositif
    DIMENSION VISTA SYSTEM - MAGNESIUM ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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