Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products CK-MB Calibrators. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Ortho clinical diagnostics has revised the storage instructions for vitros immunodiagnostic products ck-mb calibrators. internal testing demonstrated that opened-reconstituted vitros ck-mb calibrators stored at -20degc generated invalid calibrations that were detected by positively biased quality control results.
  • Acción
    OCD is updating the instructions for use to reflect that refrigerated storage at 2-8 degrees centigrade is acceptable. OCD is asking users to discontinue use of units stored at -20 degrees centigrade. This action has been closed-out on 11/02/2016.


  • Modelo / Serial
    VITROS Immunodiagnostic Products CK-MB Calibrators. An in vitro diagnostic medical device (IVD)Product Code: 1286293
  • Manufacturer