Events

Retiro De Equipo (Recall) de DIMENSION CINICAL CHEMISTRY SYSTEM - HEMOGLOBIN A1C (HB1C) ASSAY

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS HEALTHCARE LIMITED.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    84423
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-09-24
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    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.)
  • Descripción del producto
    DIMENSION CINICAL CHEMISTRY SYSTEM - HEMOGLOBIN A
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC