Events

Recall of iQ200 Series Urine Microscopy Analyzer with Barcode Reader

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Beckman Coulter Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01420-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01420-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / 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