Events

Recall of Total IgE for use with Immulite, Immulite 1000, Immulite 2000, Immulite 2000 XPi 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 Siemens Ltd Diagnostics Division.

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-2014-RN-00003-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00003-1
  • 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 has confirmed an overall average positive bias of 23% against the who 2nd irp 75/502 with the immulite systems total ige assays. the immulite total ige controls will not detect this bias. this issue is not expected to impact patient care since the observed bias in values would not impact selection for omalizumab therapy for asthma.
  • Action
    Siemens is providing laboratories with this information to allow informed clinical decisions when undertaking Total IgE testing. There are currently no unaffected batches available in Australia. A lookback of previously generated results is a the discretion of the laboratory.

Device

Total IgE for use with Immulite, Immulite 1000, Immulite 2000, Immulite 2000 XPi analysers. An in...
  • Model / Serial
    Total IgE for use with Immulite, Immulite 1000, Immulite 2000, Immulite 2000 XPi analysers. An in vitro diagnostic medical device (IVD)Immulite/Immulite 1000 Total IgETest Code: TIECatalogue Number: LKIE1Seimens Material Number: 10380867Lot Number: 326 and aboveImmulite 2000/Immulite 2000 XPi Total IgETest Code: TIECatalogue Number: L2KIE2, L2KIE6Siemens Material Number: 10380873, 10380872Lot Number: 260 and aboveARTG Number: 179719
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA