Events

Retiro De Equipo (Recall) de qUAntify Control / qUAntify Plus Control. 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-00732-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-06-15
  • 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-00732-1
  • 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 observed that the values for blood and ketones may gradually decrease, and values for ph may gradually increase over the shelf life of affected product lots. this issue is not expected to impact patient results.
  • Acción
    Bio-Rad is advising users that the package insert has been updated to specify the changing values for these analytes. Laboratory means and acceptable ranges may need to be re-established for Blood, Ketones and pH during the shelf life of the product.

Device

qUAntify Control / qUAntify Plus Control. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    qUAntify Control / qUAntify Plus Control. An in vitro diagnostic medical device (IVD). Catalogue Numbers: 975, 975X, 995, 995X (12 mL), 962, 963, 964, 962X (120 mL)Lot Numbers: 78770, 78780, 80510, 80520, 80530, 80540, 80550, 80560, 79610, 79620, 79630, 79640, 79650, 79660ARTG Number: 206309Bio-Rad Laboratories - Clinical chemistry biological screening IVDs
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd