Events

Retiro De Equipo (Recall) de Phadia 1000 Instrument (Allergy testing system). 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 Abacus ALS 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-2014-RN-01290-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-11
  • 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-2014-RN-01290-1
  • 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
    A mismatch between the sample id and the test result reported will occur if the following specific circumstances occur. 1. a barcode reading error 0-1502 occurs (error #1)2. the operator then selects “enter id” in order to manually assign the sample tube a sample id number3. another error message of any kind occurs (error #2) before the sample id is entered (the “enter id” screen remains open on the instrument)4. when more than 5 minutes elapse after “error #2” occurs, but before the “enter id” screen is closed by the operator, a third error (error #3) occurs which requires a response from the operator5. the operator then closes the “enter id” screen by touching either the “rack pass” or “back” buttons on the touch screenthis will result in a mismatch between for all subsequent sample racks in that run.
  • Acción
    Abacus ALS is providing a software update to correct the issue. Until the software update is installed end users are requested to take the following actions: If a user is presented with a 0-1502 error, BAR CODE ERROR (Sample Rack): - select “Pass” (i.e., do not select “Enter ID”), or - do nothing (since the error will be automatically released after more than five minutes). Any sample with a barcode reading error will then not be processed. It may be processed later in the run after the sample rack has been ejected from the sampling area. This action has been closed-out on 04/04/2017.

Device

Phadia 1000 Instrument (Allergy testing system). An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Phadia 1000 Instrument (Allergy testing system). An in vitro diagnostic medical device (IVD) Part Number: 12-3800-01 ARTG Number: 192561
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd