Events

Retiro De Equipo (Recall) de WIZARD2 Gamma Counters

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

¿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-00417-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-18
  • 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-00417-1
  • 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
    Perkinelmer have become aware through a customer complaint that the content of the second of the two #023 barcode id labels provided on each page of the barcode id label binder are incorrect. the second barcode id label #023 symbol incorrectly identifies as #024 when scanned. in the event measurement protocols have been programmed for both id #023 and #024, and the wizard2 gamma counter scans the affected barcode label, the protocol associated with barcode id #024 is executed. if the error is undetected, the wizard2 gamma counter may produce erroneous results.The impact on health is dependent on the clinical application in which the wizard2 gamma counter is being used.The issue will lead to a delay in reporting results due to the delay to resolve the issue and retest the samples or test new samples. dependent on individual patient clinical status an incorrect result may impact disease progression or renal function.
  • Acción
    Users are advised to ensure that they remove the barcode labels ID #023 from all barcode label binders in their possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks. A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided to affected customers. This action has been closed-out on 08/08/2016.

Device

WIZARD2 Gamma Counters
  • Modelo / Serial
    WIZARD2 Gamma CountersWIZARD2 1-detector, 550 samples2470-0010Serial Numbers (SN):DG07129377, SGWZ33130034, SGWZ45130065, SGWZ32140180WIZARD2 2-detector, 550 2470-0020SN:DG12120038, SGWZ39130048WIZARD2 5-detector, 550 2470-0050 SN:SGWZ30140174, SGWZ46140216WIZARD2 5-detector, 10002470-0150 SN:SGWZ36130042WIZARD2 1-detector, 3",10002480-0010SN:DG10129717, DG03130240, SGWZ20130008, SGWZ23130015, SGWZ45130066, SGWZ08140110, SGWZ08140111ARTG number: 209297
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer