Events

Retiro De Equipo (Recall) de Dynabeads HLA Class II and Dynabeads HLA Cell Prep II. 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 Bio-Strategy 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-00645-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-22
  • 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-00645-1
  • 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
    The manufacturer has recently identified an impurity (bacterial endotoxins) in the raw material used for the final formulation of the finished product of dynabeads hla class ii and dynabeads hla cell prep ii. their investigation determined that the presence of these endotoxins along with any deviation from the recommended cell isolation temperature in the user manual (e.G. performing some steps or storing product at room temperature) may reduce cell viability and lead to failure of the negative control.
  • Acción
    Bio-Strategy are advising users to discontinue use of the affected material immediately, and to quarantine and place all unused product in a box at ambient temperature ready for collection. Bio-Strategy will arrange for the collection, and will provide replacement product or issue credit..

Device

Dynabeads HLA Class II and Dynabeads HLA Cell Prep II. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Dynabeads HLA Class II and Dynabeads HLA Cell Prep II. An in vitro diagnostic medical device (IVD)Dynabeads HLA Class IICatalogue Number: 21003Lot Numbers: 00461955, 00477414, 00480193Catalogue Number: 21004DLot Numbers: 00461951, 00469604, 00477401, 00480209 Dynabeads HLA Cell Prep IICatalogue Number: 21903Lot Number: 00469606, 00477408, 00480204Catalogue Number: 21904Lot Numbers: 00455989, 00461965, 00469615, 00492942
  • Manufacturer
    Bio-Strategy Pty Ltd

Manufacturer

Bio-Strategy Pty Ltd