Events

Recall of IMMULITE Systems 1000 / 2000 / 2000 XPi CMV IgM Assay (used for the determination of Cytomegalovirus (CMV)). 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 Siemens Healthcare 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-2016-RN-01164-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01164-1
  • 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
    Siemens healthcare diagnostics has identified increased imprecision on some patient samples with the affected cmv igm reagent lots identified on the immulite / immulite 1000 and the immulite 2000 / immulite 2000 xpi systems. these samples may exhibit higher percent coefficient of variation (% cv) than the precision performance data published in the instructions for use (ifu) across nonreactive, indeterminate, and reactive ratios. quality controls provided in the cmv igm kit may not detect the imprecision with patient results. siemens is continuing to investigate the cause of the imprecision. the risk to health is remote and limited to a falsely nonreactive result when truly indeterminate or reactive, which may lead to delayed investigation of acute cmv infection.
  • Action
    Siemens is advising users to discontinue use and discard the affected batches, and recommends transitioning to IMMULITE/IMMULITE 1000 kit lot 0332 and above and IMMULITE 2000/2000 XPi CMV IgM kit lots 268 and above. Siemens is recommending a look back, including retesting of existing samples provided specimens meet time and storage conditions specified in the Instructions for Use, for previously generated nonreactive results of =0.40 and <0.9. Retesting using CMV IgM or another appropriate CMV test, depending on the clinical context and timing of the initial test, may be considered.

Device

IMMULITE Systems 1000 / 2000 / 2000 XPi CMV IgM Assay (used for the determination of Cytomegalovi...
  • Model / Serial
    IMMULITE Systems 1000 / 2000 / 2000 XPi CMV IgM Assay (used for the determination of Cytomegalovirus (CMV)). An in vitro diagnostic medical device (IVD)Immulite / Immulite 1000Test Code: CMMCatalogue Number: LKCM1Siemens Material Number: 10381296Lot Numbers: 0330 and 0331Immulite 2000 / 2000 XPiTest Code: CMMCatalogue Number: L2KCM2Siemens Material Number: 10381320Lot Numbers: 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 266, 267ARTG Number: 208726
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA