Events

Recall of HemoCue WBC Diff analysers and WBC Diff Microcuvettes. 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 Radiometer Pacific 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-2018-RN-00161-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00161-1
  • 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
    No specific limitations are given in the indications for use for the system. however, hemocue has become aware that there is a need to clarify that use of the hemocue wbc diff system on patients on chemotherapy, other immunosuppressive therapies or on drugs with immunosuppressive effects, has not been fully evaluated by hemocue ab.Riskif incorrect results are obtained for these patient populations it could potentially lead to a delay in a dose modification and increased infection risk.Hemocue will be updating the instruction for use for the wbc diff system to include the above clarification.
  • Action
    Radiometer will be providing updated instructions for use to provide clarification regarding the use of the HemoCue WBC Diff system on patients on chemotherapy, other immunosuppressive therapies or on drugs with immunosuppressive effects.

Device

HemoCue WBC Diff analysers and WBC Diff Microcuvettes. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    HemoCue WBC Diff analysers and WBC Diff Microcuvettes. An in vitro diagnostic medical device (IVD)All Serial NumbersARTG Numbers: 222568, 222701(Radiometer Pacific - Haematology full blood count IVDs)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd