Events

Recall of Immulite / Immulite 1000 XPi IGF-1 and Immulite 2000 / Immulite 2000 XPi IGF-1. 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-2012-RN-01174-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01174-1
  • 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 manufacturer confirms a positive shift in patient medians of approximately 20% with the igf-1 assay. the manufacturer advises that the performance of kit lots currently in distribution is in alignment with the medians of the reference data range published in instructions for use. additionally, siemens wants to notify customers of an upcoming major supply disruption.
  • Action
    Laboratories to implement the work-around provided by the sponsor. A review of previously reported results should be considered.

Device

Immulite / Immulite 1000 XPi IGF-1 and Immulite 2000 / Immulite 2000 XPi IGF-1. An in vitro diagn...
  • Model / Serial
    Immulite / Immulite 1000 XPi IGF-1 and Immulite 2000 / Immulite 2000 XPi IGF-1. An in vitro diagnostic medical device (IVD)Immulite / Immulite 1000 XPi IGF-1Catalogue Number: L2KGFSiemens Material Number: 10381448Lot Number: 441-492Immulite 2000 / Immulite 2000 XPi IGF-1Catalogue Number: LKGF1Siemens Material Number: 10381403Lot Number: 315-334ARTG Number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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