Events

Retiro De Equipo (Recall) de STAGO STA SYSTEM - LIQUID ANTI-XA 4

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por STAGO CANADA LTD./STAGO CANADA LTEE.

¿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
    82611
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-07-30
  • 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
    The stago hotline/call center has received some customer complaints regarding a misreading of reagent 1 (substrate)barcode on sta analyzers. diagnostica stago has investigated and confirmed that the barcode is incorrectly coded. consequently when the barcode is scanned on sta analyzers the last 3 digits displayed are "066" instead of "366". when the corresponding flyer is scanned the sta analyzer displays an error message because the lot of the vial does not match with the lot on the flyer. it is a labelling issue however the defect is only in the barcode the lot number 112366 printed on the vial is correct.

Device

STAGO STA SYSTEM - LIQUID ANTI-XA 4

Manufacturer

STAGO CANADA LTD./STAGO CANADA LTEE