Events

Recall of Reflotron Uric Acid (used with Reflotron Plus & Reflotron Sprint Single test chemistry systems) An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

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-2015-RN-01239-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01239-1
  • 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
    The internal investigation detected deviations in uric acid results on the reflotron system which can be above the internal specification of 5%, if the haematocrit values in whole blood samples exceed 48%. this may lead to erroneously low uric acid results in such blood samples. roche diagnostics are updating the product insert to include the revised limit.
  • Action
    Roche Diagnostics is advising users to note the haematocrit value limit has been reduced to a maximum of 48%, and advises users to take this into account when measuring patient samples from whole blood. Roche Diagnostics will be updating the Product Insert as a permanent correction.

Device

Reflotron Uric Acid (used with Reflotron Plus & Reflotron Sprint Single test chemistry systems) A...
  • Model / Serial
    Reflotron Uric Acid (used with Reflotron Plus & Reflotron Sprint Single test chemistry systems) An in vitro diagnostic medical device (IVD)Material Number: 10745103202All lot numbers affectedARTG number: 174909
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited