Events

Retiro De Equipo (Recall) de ID Anti-N and ID Anti-M/N. 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-Rad Laboratories 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-00373-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-07
  • 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-00373-1
  • 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
    It has been confirmed that in specific conditions, the anti-n (mns2) of certain lots of cards id-diaclon anti-n (ref. 007111) and id-diaclon anti-m/n (ref. 006011) may give an unexpected interference with n negative samples.Investigations have identified that this phenomenon is temperature dependent, becoming stronger if the ambient temperature drops to the lower range of room temperature, 18-25°c and tending to disappear once the temperature reaches the upper limit of this range. reagents and samples that are at the lower end of the room temperature range will also increase the interference.The reported issue may result in false positive results which can lead to a delay in transfusion decisions.
  • Acción
    Bio-Rad is advising users NOT to validate a positive result that gives reaction strength lower than 3. The automatic validation function on the instruments should be disabled when carrying out tests MO45D and PR44N. Bio-Rad will provide manual test kits to confirm the results obtained for negative 1+ and 2+ reactions when requested. The sponsor is working on a permanent solution and the users will be notified once unaffected products become available. This action has been closed-out on 09/05/2017.

Device

ID Anti-N and ID Anti-M/N. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ID Anti-N and ID Anti-M/N. An in vitro diagnostic medical device (IVD)ID-DiaClon Anti-N Catalogue Number: 007111Test Code (for instrument): PR44NLot Number: From lot 50221.73.01 onwardsID-DiaClon Anti-M/NCatalogue Number: 006011Test Code (for instrument): MO45DLot Number: From lot 51210.52.01 onwardsARTG Number: 217696
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd