Events

Retiro De Equipo (Recall) de MRSASelect II agar. 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-2018-RN-00703-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-14
  • 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-2018-RN-00703-1
  • 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
    Bio-rad have identified that certain lots of mrsaselect ii agar may have abnormal colouration and growth of non-characteristic mrsa colonies.If plates were exposed to light but none defects have been detected before use, then mrsa colonies may appear white to yellow instead of the pink characteristic colour, or the growth may be delayed. as a result, there is a risk of misinterpretation of the result.
  • Acción
    Bio-Rad is advising: - For the references and batches of affected product, do not expose the boxes more than 4 hours to light during the intermediate storage steps, including returning at room temperature, and during incubation until the reading step. - Do not use a suspicious colour agar. - As recommended in the package insert, if in doubt, confirm the identification of colonies by coagulase test or Pastorex Staph Plus.

Device

MRSASelect II agar. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    MRSASelect II agar. An in vitro diagnostic medical device (IVD).Catalogue Numbers: 63757 & 63759Multiple Lot NumbersARTG Number. 188609(Bio-Rad Laboratories - Microbiological culture media IVDs)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd