Recall of Immulite 2000 and Immulite 2000 XPi – Italian Cypress Allergen

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
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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 confirmed that the immulite 2000/immulite 2000 xpi italian cypress allergen lot 206 does not meet the shelf-life stability as indicated on the label. this may lead to single class change decrease (standard classification) in patient results across the current shelf-life of this allergen lot. patient dose values may decrease before the stated expiry date listed on the allergen vial.It is expected that lot 208 will also not meet its current shelf life stability and must be discarded after june 30, 2015.
  • Action
    Siemens is requesting laboratories to discard IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen from lot 206. The shelf-life of IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 208, has been shortened to June 30, 2015. Laboratories are requested to discontinue use and discard lot 208 after June 30, 2015.


  • Model / Serial
    Immulite 2000 and Immulite 2000 XPi – Italian Cypress AllergenSiemens Material Number: 10386079Lot Numbers: 206 and 208ARTG number: 198420
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source