Events

Retiro De Equipo (Recall) de Ortho Clinical Diagnostics Vitros Chemistry Product Na Slides

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Ortho-Clinical Diagnostics 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
    20995
  • Fecha de inicio del evento
    2017-11-03
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Ortho-Clinical Diagnostics, c/o Quigg Partners, Level 7, 36 Brandon Street, Wellington 6011
  • Causa
    The manufacturer has identified the potential for biased results to be generated over the 10 day on-analyzer limit when using vitros na+ slide cartridges warmed between 1 1/2 to 8 hours then placed on the analyzer. the manufacturer has determined that cartridges require a minimum of 8 hours of warm up at room temperature to help ensure the slides have acceptable performance throughout the 10 day on-analyzer storage limit., follow up and resolution november 2017, the manufacturer is introducing vitros electrolyte reference fluid (erf) 300 and vitros electrolyte reference fluid (erf) 800 with a revised formulation that:, 1. restores the na+ cartridge warm-up protocol to 90 minutes when taken from the refrigerator (120 minutes from the freezer) as defined in the vitros na+ slides instructions for use., 2. reformulated erf helps to reduce sources of variability (e.G., calibration variability) observed when using vitros na+ slides.
  • Acción
    Manufacturer to issue advice regarding use

Device

Ortho Clinical Diagnostics Vitros Chemistry Product Na Slides

Manufacturer

Ortho-Clinical Diagnostics Inc