Events

Retiro De Equipo (Recall) de iQ200 Series Urine Microscopy Analyzer with Barcode Reader

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Beckman Coulter 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-2017-RN-01420-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-16
  • 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-2017-RN-01420-1
  • 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
    Iris international has determined that the iq200 series urine microscopy analyzer with barcode reader (model nft-2100), may intermittently exhibit the following: ? failure to read the urine sample dilution barcode label where it defaults to a dilution factor of 1:1 and does not apply the correct dilution factor. ? failure to read body fluid dilution barcode label where the rack is rejected and no results are generated. when the iq series analyzer fails to read the urine sample dilution barcode label, erroneous results with incorrect concentrations and inaccurate particle counts for any formed particles will be generated. ? incorrect patient results will be observed as an unexpected discrepancy between instrument results and the patient's clinical picture. ? the greatest impact could be a delay in recognition of hematuria.
  • Acción
    Beckman Coulter is working on a resolution to correct and prevent recurrence of this issue. Until then, anytime a dilution has been made, the laboratory must verify that the dilution factor is correct before release of final results. If Auto-Release is used, the printing option should always be enabled for result release and the printout verified. If Auto-Release is not used, verify that the dilution factor is correct on the specimen screen and if thedilution factor is incorrect, delete results and create a manual order for the specimen with the correct dilution factor. Users are requested to share this information with staff and retain this notification as part of laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. Advise Beckman Coutler within 10 days ofreceiving this notice as directed.

Device

iQ200 Series Urine Microscopy Analyzer with Barcode Reader
  • Modelo / Serial
    iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100 Multiple part numbersARTG number: 181116
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd