Events

Retiro De Equipo (Recall) de VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH results generated on VITROS 4600 Chemistry System, VITROS 5600 Integrated System and VITROS 5,1 FS Chemistry System

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
    Recall
  • ID del evento
    RC-2014-RN-00502-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-07
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00502-1
  • 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
    This recall action has been initiated by ortho-clinical diagnostics, inc. (ocd) due to the potential for biased results when a multiple window (mw) code is associated with results generated by the vitros® systems listed. a mw code is a flag/error code generated when a potential issue with the results calculation is detected. this code does not suppress the sample result. a mw code is a flag/error code generated when a potential issue with the results calculation is detected. this code does not suppress the sample result.
  • Acción
    Ortho-Clinical Diagnostics (OCD) will resolve this issue in a future software release. To assist in the interim OCD is providing a procedure for reviewing VITROS chemistry results and MW codes. This action has been closed-out on 11/02/2016.

Device

VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH results generated on VITROS 4600 Chemistry System, VI...
  • Modelo / Serial
    VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH results generated on VITROS 4600 Chemistry System, VITROS 5600 Integrated System and VITROS 5,1 FS Chemistry SystemVITROS 4600 Chemistry SystemProduct Code: 6802445Affected Software Versions: 3.0 and lowerVITROS 5600 Integrated SystemProduct Code: 6802413Affected Software Versions: 3.0 and lowerVITROS 5,1 FS Chemistry SystemProduct Codes: 6801375, 6801890Affected Software Versions: 2.7 and lowerMultiple assays affected
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics