Events

Rappel de DIMENSION CINICAL CHEMISTRY SYSTEM - HEMOGLOBIN A1C (HB1C) 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
    84423
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-09-24
  • 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 is conducting a field recall for the for dimension vista hba1c and dimension hb1c flex reagent lots listed in section 64(a) of this report. siemens has confirmed that these reagent cartridge lots exhibit a positive bias averaging 0.4% [4.4 mmol/mol] hemoglobin a1c units and occasionally up to 1.0% [11 mmol/mol] hba1c units for patient samples when compared to the national glycohemoglobin standardization program (ngsp). qc samples may exhibit a similar bias. as the customer base may differ based on the platform being utilized siemens is issuing two urgent field notices: one ufsn is being issued for the affected lots of dimension vista hemoglobin a1c (hba1c). the second ufsn is being issued for the affected lots of dimension hemoglobin a1c (hb21c). customers will receive the letters pertinent to them. both letters contain the same content differing only in the specified product code and lot numbers.

Device

DIMENSION CINICAL CHEMISTRY SYSTEM - HEMOGLOBIN A1C (HB1C) ASSAY
  • Modèle / numéro de série
    Model Catalog: 10483822 (Lot serial: >10 contact mfg.); Model Catalog: DF105A (Lot serial: >10 contact mfg.); Model Catalog: 10470481 (Lot serial: >10 contact mfg.); Model Catalog: K3105A (Lot serial: >10 contact mfg.)
  • Description du dispositif
    DIMENSION CINICAL CHEMISTRY SYSTEM - HEMOGLOBIN A
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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