Events

Recall of Fluorocell PLT reagent. An in vitro diagnostic medical device (IVD)(used on Sysmex XN-10 and XN-20 Automated Haematology Analysers)

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-2017-RN-01275-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01275-1
  • 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
    Sysmex has advised that specific lots of the fluorocell plt reagent may be susceptible to environmental factors causing a decrease in their fluorescence over time. in such instances, the affected lots could lead to a false low plt-f value, which will be inconsistent with the plt-i value.
  • Action
    Roche is advising customers to discard any affected lots of Fluorocell PLT in use or stock. If available, users should use cartridges of an unaffected lot of Fluorocell PLT. Users should ensure that they perform reagent replenishment for Fluorocell PLT to flush out the old lot and completely replenish with unaffected reagent. If no other lot of Fluorocell PLT is available, please check PLT-F results for plausibility. If the PLT-F results are not plausible, please refer to the PLT-I results from the impedance channel. Users should follow internal SOP's regarding retrospective judgement of affected samples. Contact Roche Diagnostics Australia to discuss the need for replacement product.

Device

Fluorocell PLT reagent. An in vitro diagnostic medical device (IVD)(used on Sysmex XN-10 and XN-2...
  • Model / Serial
    Fluorocell PLT reagent. An in vitro diagnostic medical device (IVD)(used on Sysmex XN-10 and XN-20 Automated Haematology Analysers)Fluorocell PLT 2 x 12 mLLot Numbers: A6051 to A6090ARTG Number: 188498
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited