Events

Rappel de IMMULITE 2000 SYSTEM - ESTRADIOL 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
    19549
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-11-02
  • 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 confirmed that a small percentage of bead packs may intermittently fail to dispense a bead as a result of an issue with the bead pack plunger assembly. through the investigation of customer complaints and in collaboration with our supplier the frequency of occurrence has been determined as approximately 0.02%.

Device

IMMULITE 2000 SYSTEM - ESTRADIOL ASSAY
  • Modèle / numéro de série
    Model Catalog: L2KE22 (Lot serial: ALL); Model Catalog: L2KVB6 (Lot serial: ALL); Model Catalog: L2KVB2 (Lot serial: ALL); Model Catalog: L2KCL2 (Lot serial: ALL); Model Catalog: L2KRUB6 (Lot serial: ALL); Model Catalog: L2KRUB2 (Lot serial: ALL); Model Catalog: L2KTW6 (Lot serial: ALL); Model Catalog: L2KTW2 (Lot serial: ALL); Model Catalog: L2KT36 (Lot serial: ALL); Model Catalog: L2KT32 (Lot serial: ALL); Model Catalog: L2KTI6 (Lot serial: ALL); Model Catalog: L2KTI2 (Lot serial: ALL); Model Catalog: L2KDS2 (Lot serial: ALL); Model Catalog: L2KGB2 (Lot serial: ALL); Model Catalog: L2KCM6 (Lot serial: ALL); Model Catalog: L2KCM2 (Lot serial: ALL); Model Catalog: L2KCRP2 (Lot serial: ALL); Model Catalog: L2KON2 (Lot serial: ALL); Model Catalog: L2KTU2 (Lot serial: ALL); Model Catalog: L2KHB6 (Lot serial: ALL); Model Catalog: L2KHB2 (Lot serial: ALL); Model Catalog: L2KHPG6 (Lot serial: ALL); Model Catalog: L2KHPG2 (Lot serial: ALL); Model Catalog: L2KIP6 (Lot serial: ALL); Model Catalog: L2KIP2 (Lot serial:
  • Description du dispositif
    IMMULITE 2000 SYSTEM-ESTRADIOL ASSAY;IMMULITE 2000 SYSTEM- VITAMIN B12 ASSAY;IMMULITE 2000 SYSTEM- CALCITONIN ASSAY;IMMULITE 2000 RUBELLA QUANTITATIVE IGG;IMMULITE 2000 SYSTEM-TESTOSTERONE ASSAY;IMMULITE 2000 SYSTEM- TOTAL T3 ASSAY;IMMULITE 2000 SYSTEM- T
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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