Events

Recall of Multiplate Analyser. 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 Haemoview Diagnostics.

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-00734-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00734-1
  • 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 identified that specific multiplate stirrer boards (replaced by another type 7.5 years ago) may develop an increasing stirring speed above specification. all channels are affected in the same way. too high stirrer speed may correlate with a falsely decreased recovery and therefore may lead to falsely low patient results. investigation has showed in maximum a reduced recovery of 80% (= bias -20%) and that the degree of decreased recovery depends on assay, with adp, trap, aspi more affected than col. although no testing was performed for the ristotest and adptest hs, similar low recovery of platelet function test results is assumed for these tests. in case of falsely low patient results due to falsely decreased recovery of platelet function tests (adptest, aspitest, traptest, coltest, ristotest adp hs test) the platelet function in diagnostic measures may be incorrectly interpreted as impaired.
  • Action
    A Haemoview Diagnostics representative will schedule the necessary repair measures with the user. Until then, the affected Multiplate Analyser must not be used for diagnostic purposes. A loan device will be provided.

Device

Multiplate Analyser. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Multiplate Analyser. An in vitro diagnostic medical device (IVD)Product Code: 06675069001Serial Number: 100365ARTG Number: 263172
  • Manufacturer
    Haemoview Diagnostics

Manufacturer

Haemoview Diagnostics