Events

Recall of Roche Reflotron Uric Acid Test

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    18822
  • Event Initiated Date
    2015-07-13
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Reason
    Roche diagnostics has reduced the hematocrit value to a maximum of 48% for the reflotron uric acid test when measuring patient samples from whole blood., the internal investigation detected deviations in uric acid results on reflotron system, which can be above the internal specification of 5%, if the hematocrit values exceed 48%. this may lead to erroneously low uric acid results in blood samples with hematocrit values higher than 48%.
  • Action
    Instructions for use to be updated

Device

Roche Reflotron Uric Acid Test
  • Model / Serial
    Model: Material Number: 10745103202, Affected: All lots
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479