Events

Retiro De Equipo (Recall) de VITROS Chemistry Products Slide Assays - GLU, LAC, TRIG, URIC. 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
    Recall
  • ID del evento
    RC-2016-RN-01118-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-25
  • 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-01118-1
  • 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
    1. ortho clinical diagnostics (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. 2. ortho has also found that dextran 40 and glutathione may also interfere with vitros glu slides and cause biased results.To date, ortho is not aware of any misreported patient results associated with this issue all expired, current/in-date and future generations (gens) of the assays are affected.
  • Acción
    The Instructions for Use (IFUs) for the affected assays (GLU, LAC, TRIG, URIC) will be revised to include the interferent information in the Limitations of the Procedure section. Ortho is advising users that biased results may occur for patient sample containing these substances and is providing the results of the interference testing undertaken with these substances. The affected VITROS Slide Assays can continue to be used, with consideration of the new potential interferents. Any concerns regarding previously reported results should be discussed with the Laboratory Medical Director to determine the appropriate course of action.

Device

VITROS Chemistry Products Slide Assays - GLU, LAC, TRIG, URIC. An in vitro diagnostic medical dev...
  • Modelo / Serial
    VITROS Chemistry Products Slide Assays - GLU, LAC, TRIG, URIC. An in vitro diagnostic medical device (IVD)GLU SlidesProduct Code: 1707801Current/In-date Generations (GENs): 10, 11, 20 through 31LAC SlidesProduct Codes: 8433880, 8150112Current/In-date GENs: 30, 31TRIG SlidesProduct Codes: 1336544, 8329930Current/In-date GENs: 16, 17, 19, 20, 22, 23, 24, 25, 27 through 32URIC SlidesProduct Code: 1943927Current/In-date GENs: 26, 27, 28, 29, 31ARTG Number: 232248
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics