Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS SYSTEM - LAC SLIDES (LACTATE)

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
    46557
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-08-16
  • País del evento
  • 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
    This recall was initiated because ortho was made aware of new information regarding the potential for n-acetylcysteine (nac) to interfere with specific vitros chemistry products slide assays (glu lac trig and uric). patients who were administered nac could potentially have biased sample results.

Device

  • Modelo / Serial
    Model Catalog: 8433880 (Lot serial: > 10 contact manufacturer); Model Catalog: 8150112 (Lot serial: > 10 contact manufacturer); Model Catalog: 1336544 (Lot serial: > 10 contact manufacturer); Model Catalog: 8329930 (Lot serial: > 10 contact manufacturer); Model Catalog: 1943927 (Lot serial: > 10 contact manufacturer); Model Catalog: 1707801 (Lot serial: > 10 contact manufacturer)
  • Descripción del producto
    VITROS Chemistry Products LAC Slides;VITROS Chemistry Products TRIG Slides;VITROS Chemistry Products URIC Slides;VITROS Chemistry Products GLU Slides
  • Manufacturer

Manufacturer