Events

Retiro De Equipo (Recall) de Magnetic Silica MagSIL. An in vitro diagnostic medical device (IVD).(used with NucliSENS easyMAG/eMAG nucleic acid extraction system for automated extraction of total nucleic acids (RNA/DNA) from biological samples)

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-00224-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-02-27
  • 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-00224-1
  • 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
    In july 2016 customers were informed about a decrease of extraction performances for some specific downstream applications with 7 batches of magsil, which can lead to a risk of false negative, invalid or under-quantification results (tga ref.: rc-2016-rn-00949-1). following this action, biomérieux put in place several additional quality controls (qc) at the release of batches. the released batches performances have been monitored in real-time for stability. as a result, in jan 2017 customers were informed that the issue may affect a further 8 magsil batches (tga ref.: rc-2016-rn-01551-1).The corrective actions provided for the batches under rc-2016-rn-01551-1 remain appropriate. for the 7 batches included in the july 2017 action, a drift of the performance results was observed after a few months of release with the biomérieux bk-virus r-gene test. since one biomérieux assay is impacted, the usability of these batches with all biomérieux applications cannot be assured.
  • Acción
    bioMérieux is advising customers to quarantine the remaining kit from lots Z017BB1MS, Z017BF1MS, Z017BA1MS, Z017CC1MS, Z017CG1MS, Z017DC1MS & Z017DD1MS. bioMérieux will arrange for the return of these kits and also credit/replacement. Any concerns regarding previously reported results should be discussed with the Laboratory Director to determine the appropriate course of action.

Device

Magnetic Silica MagSIL. An in vitro diagnostic medical device (IVD).(used with NucliSENS easyMAG/...
  • Modelo / Serial
    Magnetic Silica MagSIL. An in vitro diagnostic medical device (IVD).(used with NucliSENS easyMAG/eMAG nucleic acid extraction system for automated extraction of total nucleic acids (RNA/DNA) from biological samples)Lot Numbers:Z017BB1MS, Z017BF1MS, Z017BA1MS Expiry Date: 28/02/2017Z017CC1MS, Z017CG1MS Expiry Date: 28/03/2017Z017DC1MS, Z017DD1MSExpiry Date: 28/04/2017ARTG Number: 240760
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd