Events

Rappel de iQ200 Series Urine Microscopy Analyzer with Barcode Reader

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Beckman Coulter Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-01420-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-16
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01420-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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