Events

Retiro De Equipo (Recall) de VERSATREK 240 SYSTEM - INSTRUMENT

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

¿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
    21538
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-06-12
  • 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
    An internal investigation has shown that the use of the versatrek automated microbial detection system might result in false positive reports. to date three (3) customer complaints have been received all in conjunction with versatrek myco bottle usage. review of instrument databases suggests that on rare occasions the barometric pressure readings may be inconsistent. this event is caused by a protective sticker covering the sensor. if this sticker forms a complete seal it traps air under the sticker resulting in incorrect atmospheric pressure readings. this in turn leads to reports of false positives.

Device

VERSATREK 240 SYSTEM - INSTRUMENT
  • Modelo / Serial
    Model Catalog: 6240-04 (Lot serial: 2208X1113); Model Catalog: 6528-22 (Lot serial: 2298X0714)
  • Descripción del producto
    VERSATREK AUTOMATED MICROBIAL DETECTION SYSTEM (240 MODEL)
  • Manufacturer
    OXOID COMPANY

Manufacturer

OXOID COMPANY