Events

Retiro De Equipo (Recall) de BK Virus R-gene Real-time Detection and Quantification Kit. 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 Biomerieux 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-2017-RN-00806-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-06-23
  • 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-2017-RN-00806-1
  • 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
    Biomérieux has observed significant differences between the fit point and 2nd derivative analysis methods on lightcycler amplification platforms for low positive whole blood samples.Investigation showed that the significant differences (>0,5 log10 cp/ml) have been obtained for bk virus low viral loads (inferior to around 25 000 cp/ml - corresponding to around 4.40 log10 cp/ml - determined by fit point) on whole blood samples with the bk virus r-gene assay. these differences between the two methods are due to the shape of the curves for low positive whole blood samples.
  • Acción
    Users are requested to take the following actions at this time: ? Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. ? Stop using the 2nd derivative method for whole blood samples on LightCycler 1.0, 2.0 and 480 until the improved BK Virus R-gene kit was released. Use the Fit Point method with these LightCyclers. ? Contact your local customer service if you observe the issue.

Device

BK Virus R-gene Real-time Detection and Quantification Kit. An in vitro diagnostic medical device...
  • Modelo / Serial
    BK Virus R-gene Real-time Detection and Quantification Kit. An in vitro diagnostic medical device (IVD)Reference Number: 69-013BPack Size: 90 testsIFU Version: 21258D Lot Numbers: 1004754140 and 1004764070 Expiration Date: 4 Feb 2018IFU Version: 21258E (new version) Lot Numbers: 1004965280Expiration Date: 22 Nov 2018ARTG Number: 211361
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd