Events

Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS SYSTEM - ALT SLIDES (ALKALINE AMINOTRANSFERASE)

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
    55603
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-02-13
  • 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 received complaints of lower than expected results (<6 u/l) for samples that were known to be outside of the measuring range (>1000 u/l) when using calibration diskette/assay data diskette data release version (drv) 5653 through 5666 and vitros chemistry products alt slides (gen 26). internal investigation determined that the diskettes did not contain the appropriate supplementary calibration data for vitros alt slides (gen 26) used to flag samples greater than 1000 u/l that may have depleted the substrate. sample results that were reported between 6-1000 u/l are not affected by this issue. to correct the issue all customers that received vitros alt slides (gen 26) will be shipped drv 5667 which contains revised supplementary calibration data that will appropriately flag a sample that causes substrate depletion. following download and successful recalibration it is acceptable to resume using vitros alt slides (gen 26).

Device

VITROS CHEMISTRY PRODUCTS SYSTEM - ALT SLIDES (ALKALINE AMINOTRANSFERASE)
  • Modelo / Serial
    Model Catalog: 1655281 (Lot serial: 622-0421-0410)
  • Descripción del producto
    VITROS Chemistry Products ALT Slides
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS