Events

Recall of Lysercell WDF 2 x 4L used on Sysmex XN-Series Automated Haematology Analysers. 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-2017-RN-00159-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00159-1
  • 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
    Roche diagnostics australia has received several reports that lysercell wdf 2 x 4l lots a6028, a6029 and a6030 can lead to an increased occurrence (up to 3-fold) of the flag “blast/abn lympho?” . no other flags have been observed. this issue leads to an increase in the “blast/abn lympho?” flagging rate and unnecessary manual review. the risk of a misdiagnosis is mitigated by the fact that any flags observed from the affected instruments must be confirmed by a qualified morphologist using a manual blood film.
  • Action
    Roche is advising customers to immediately discontinue use of and quarantine affected lots. New replacement lots will be provided by Roche.

Device

Lysercell WDF 2 x 4L used on Sysmex XN-Series Automated Haematology Analysers. An in vitro diagno...
  • Model / Serial
    Lysercell WDF 2 x 4L used on Sysmex XN-Series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD).Material Number: 06510221001Lot Numbers: A6028, A6029, A6030ARTG Number: 188498
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited