Events

Retiro De Equipo (Recall) de AUTOSTAINER 48 LINK

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por AGILENT TECHNOLOGIES CANADA INC..

¿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
    80208
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-02-24
  • 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
    A leaking stopcock spare part (922640 rev.02) used in the autostainer isntrument family has been obersved. feedback from service engineers indicate that the stopcock component of the syringe assembly is leaking around the plunger in the stopcock when the prove is being washed/flushed. this could result in a reduced intensity score giving a false negative result in harceptest but does not affect the clinical outcome of any other reagents.

Device

AUTOSTAINER 48 LINK
  • Modelo / Serial
    Model Catalog: AS480 (Lot serial: AS48-0363-01); Model Catalog: AS480 (Lot serial: AS2041D1106); Model Catalog: AS480 (Lot serial: AS2042D1106); Model Catalog: AS480 (Lot serial: AS2044D1106); Model Catalog: AS480 (Lot serial: all lots. contact mfg); Model Catalog: AS480 (Lot serial: AS1474D0910); Model Catalog: AS480 (Lot serial: AS2040D1106); Model Catalog: AS480 (Lot serial: AS1766D1010); Model Catalog: AS480 (Lot serial: AS48-0204-01); Model Catalog: AS100 (Lot serial: all lots. contact mfg); Model Catalog: S3800 (Lot serial: all lots. contact mfg); Model Catalog: S3400 (Lot serial: all lots. contact mfg)
  • Descripción del producto
    Autostainer 48 Link
  • Manufacturer
    AGILENT TECHNOLOGIES CANADA INC.

Manufacturer

AGILENT TECHNOLOGIES CANADA INC.