Events

Recall of Free T3 Assays for use on the IMMULITE, IMMULITE 1000, IMMULITE 2000 and 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-2013-RN-00915-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00915-1
  • 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
    The immulite/ immulite 1000/ immulite 2000 and immulite 2000 xpi free t3 assay kit lots listed with adjustor (lf3l/h) lot #135 are showing an elevated shift in patient values that exceed the upper limits of the normal reference range referenced in the immulite free t3 instructions for use (ifu). the elevated immulite free t3 results will not correlate with the results of other thyroid markers or free t3 results generated on other platforms.
  • Action
    Siemens is requesting their customers to cease using the affected lots of reagent. Replacement with unaffected lots can be arranged to replace any stock. A look back of previously reported results is not recommended by Siemens as the assessment of thyroid function is generally based on multiple markers. However, the requirement for a look back should be determined at the discretion of the laboratory. Thia action has been closed-out on 29/01/2016.

Device

Free T3 Assays for use on the IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi analys...
  • Model / Serial
    Free T3 Assays for use on the IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi analysers. An in vitro diagnostic medical device (IVD).IMMULITE/IMMULITE 1000 FT3Catalog Number: LKF31Siemens Material Number: 10381626Lot Numbers: 353 & 354IMMULITE 2000/IMMULITE 2000 XPi FT3Catalog Numbers: L2KF32 & L2KF36Siemens Material Numbers: 10381675 & 10381682Lot Numbers: 737, 738, 739, 740, 741, 742 & 743ARTG number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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