Events

Retiro De Equipo (Recall) de PreciControl ClinChem Multi 1 Lot No. 174787 & 174794 PreciControl ClinChem Multi 2 Lot No. 174801 & 174801(Potentially all lots are affected; this issue is easily detected as the QC will be elevated. Patient samples are not affected.)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Roche Diagnostics Australia Pty Limited.

¿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-2015-RN-00957-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-09-25
  • 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-2015-RN-00957-1
  • 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
    Roche has received a number of complaints that the recovery of c-reactive protein gen. 3 (crpl3) was too high in precicontrol clinchem multi 1 (pccc1), and especially in precicontrol clinchem multi 2 (pccc2), seen mainly on the cobas c 501 module. roche diagnostics has investigated and determined that the last three reagent lots showed higher recovery for all control materials. to resolve this issue a revised target value assignment procedure was necessary. target values for currently available pccc1 and pccc2 control lots have been adjusted – as per the tables given in the customer letter.
  • Acción
    Target values for currently available PCCC1 and PCCC2 control lots have been adjusted – as per the tables given in the Customer Letter. Users are requested to use these revised values. This action has been closed-out on 04/03/2016.

Device

PreciControl ClinChem Multi 1 Lot No. 174787 & 174794 PreciControl ClinChem Multi 2 ...
  • Modelo / Serial
    PreciControl ClinChem Multi 1 Lot No. 174787 & 174794 PreciControl ClinChem Multi 2 Lot No. 174801 & 174801(Potentially all lots are affected; this issue is easily detected as the QC will be elevated. Patient samples are not affected.)ARTG number: 216332
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited