Events

Recall of IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi - Calcitonin Control Module

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-01133-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01133-1
  • 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 a typographical error in the immulite calcitonin control module instructions for use (ifu). the published expiration date in the ifu is 2017-10. the correct expiration date is 2017-01.
  • Action
    End users are requested to discard the affected product IFU and provided instructions to check the system to ensure that the correct expiry date is entered in the system. This action has been closed-out on 18/03/2016.

Device

IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi - Calcitonin Control Module
  • Model / Serial
    IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi - Calcitonin Control ModuleCatalogue Number: SMN 10385383 Lot Number: 0019ARTG Number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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