Events

Retiro De Equipo (Recall) de PTS Panels CHOL+GLU test strips. 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 Point Of Care Diagnostics 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-2018-RN-00254-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-27
  • 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-2018-RN-00254-1
  • 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
    This recall is being conducted due to the potential for loss of activity of the glucose analyte prior to the full stated shelf life (august 2018).Based on the results of internal testing, there is potential for under-recovery of the glucose analyte, and therefore, potential for lower glucose test results. this issue may result in the delay in diagnosis of diabetes. there have been no adverse events reported in conjunction with this product.
  • Acción
    Point of Care Diagnostics (PTS) is advising users to inspect stock and quarantine any remaing kits of the affected lots. Affected stock is to be destroyed. PTS will issue replacement product or a credit note.

Device

PTS Panels CHOL+GLU test strips. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    PTS Panels CHOL+GLU test strips. An in vitro diagnostic medical device (IVD)Reference Number: 1765Lot Number: A705 and A707Expiry Date: August 2018Unique Device Identification Code: Lot Numbers: A705: (01)00381931765016(17)180813(10)A705Lot Numbers: A707: (01)00381931765016(17)180828(10)A707ARTG Number: 252292(Point Of Care Diagnostics Australia - Clinical chemistry substrate IVDs)
  • Manufacturer
    Point Of Care Diagnostics Australia Pty Ltd

Manufacturer

Point Of Care Diagnostics Australia Pty Ltd