Events

Recall of Insulin-Like Growth Factor I (IGF-I) Assay (Used on Immulite and Immulite 1000 Systems). 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-00491-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00491-1
  • 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 that it takes 24 minutes of incubation prior to processing the samples on the immulite/immulite 1000 system for the patient sample and the pre-treatment solution to reach full equilibration when using pre-treatment solution (lgfa) lot 055 contained in igf-i kit lot 411. if patient samples are run before reaching full equilibration an under-recovery of up to -36% may occur. if the sample is left to incubate for more than 24 minutes prior to testing, no under recovery is observed.Quality controls (qc) will not detect this issue. there is the potential for a falsely depressed igf-i value to delay the diagnosis of acromegaly and/or delay potential pharmacologic treatment to normalise serum igf-i.
  • Action
    Siemens is advising users that the affected lot can continue to be used, however users should ensure the pre-treatment solution is allowed to incubate with the patient samples for a minimum of 24 minutes prior to processing. A review of previously generated results is at the discretion of the laboratory. This action has been closed out on 14 June 2017.

Device

Insulin-Like Growth Factor I (IGF-I) Assay (Used on Immulite and Immulite 1000 Systems). An in vi...
  • Model / Serial
    Insulin-Like Growth Factor I (IGF-I) Assay (Used on Immulite and Immulite 1000 Systems). An in vitro diagnostic medical device (IVD)Catalogue Number: LKGF1Siemens Material Number (SMN): 10381403Lot Number: 411ARTG Number: 179720
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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