Events

Retiro De Equipo (Recall) de VITROS Chemistry Products C-reactive protein (CRP) Slides

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 Australia Pty Ltd.

¿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-2016-RN-01427-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-04
  • 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-2016-RN-01427-1
  • 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
    Ortho clinical diagnostics (ortho) received reports of positively biased crp results using vitros crp slides when diluting samples. investigation undertaken by ortho identified that samples diluted (3x recommended dilution or higher) using vitros chemistry products specialty diluent, vitros chemistry products fs diluent pack 3 or a low crp concentration sample had positively biased results if the endogenous level of crp in the diluent is not subtracted from the final result. the magnitude of bias increases as the dilution factor increases.
  • Acción
    Users are advised to follow the instructions in the customer letter to perform dilutions when processing samples above the measuring range for CRP. VITROS CRP Slides Instructions for Use (IFUs) will be revised to include the additional instructions to follow when diluting samples with results above the measuring range. Discuss any concerns regarding previously reported CRP results with the Laboratory Medical Director to determine the appropriate course of action. The results from this or any other diagnostic test should be used and interpreted only within the context of the overall clinical picture. This action has been closed-out on 26/05/2017.

Device

VITROS Chemistry Products C-reactive protein (CRP) Slides
  • Modelo / Serial
    VITROS Chemistry Products C-reactive protein (CRP) SlidesProduct Codes: 1926740, 8097990Unique Identification Numbers: 10758750000296, 10758750004355Affected Generations (GENs): 3, 11, 12, 30 through 36This issue may affect expired, current (in date) and future product GENsARTG Number: 232251
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd