Events

Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS SYSTEM - CREA SLIDES (CREATININE)

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

¿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
    104022
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-06-14
  • 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
    Ocd has received an increase in customer complaints related to slide dispense issues with some vitros chemistry products slides. this increase is due to the anti-backup platen (abp) failing to advance inside the vitros chemistry products slide cartridge body causing an increase in condition codes on the vitros system. the abp is a plastic platform that supports the slide stack inside the cartridge and is pushed along with the slides to the top of the cartridge during the slide dispense cycle. if the abp is jammed within the cartridge body a slide will not be properly positioned to dispense and the system will generate a condition code. this can lead to system downtime as the user must remove the cartridge and re-seat the abp in the slide cartridge or replace it with a new cartridge.

Device

VITROS CHEMISTRY PRODUCTS SYSTEM - CREA SLIDES (CREATININE)
  • Modelo / Serial
    Model Catalog: 680 2584 (Lot serial: > 10 contact manufacturer); Model Catalog: 1988211 (Lot serial: > 10 contact manufacturer); Model Catalog: 8343386 (Lot serial: > 10 contact manufacturer); Model Catalog: 6801895 (Lot serial: > 10 contact manufacturer); Model Catalog: 1053180 (Lot serial: > 10 contact manufacturer); Model Catalog: 8102204 (Lot serial: > 10 contact manufacturer); Model Catalog: 8001133 (Lot serial: > 10 contact manufacturer); Model Catalog: 8058232 (Lot serial: > 10 contact manufacturer); Model Catalog: 8297749 (Lot serial: > 10 contact manufacturer); Model Catalog: 8159931 (Lot serial: > 10 contact manufacturer); Model Catalog: 1668409 (Lot serial: > 10 contact manufacturer); Model Catalog: 1707801 (Lot serial: > 10 contact manufacturer); Model Catalog: 1921204 (Lot serial: > 10 contact manufacturer); Model Catalog: 8255093 (Lot serial: > 10 contact manufacturer); Model Catalog: 1612365 (Lot serial: > 10 contact manufacturer); Model Catalog: 8383051 (Lot serial: > 10 contact manufacturer)
  • Descripción del producto
    VITROS CREA Slides
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS