Events

Recall of IMMULITE® 2000 IMMULITE® 2000 XPi Immunoassay System. An in vitro diagnostic medical device (IVD)Reagent Carousel Temperature Sensor Printed Circuit Board (PCB)

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-2015-RN-00369-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-04-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00369-1
  • 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 has identified that some systems may have been manufactured with a defective reagent carousel temperature sensor pcb or a defective pcb assembly.The affected temperature sensor boards may cause icing on the reagent carousel casting. if there is icing within the reagent carousel, there is a potential for the reagent carousel to encounter a mechanical jam which will stop the system from processing samples and will generate errors.Siemens has determined that the reagent contents do not freeze when the incorrectly assembled pcb assembly is installed in the reagent carousel assembly. testing shows that the reagent liquid temperature may fall below 4 °c but not to the point when freezing or slush was observed. the reagents are not compromised; therefore, assay performance is not affected.There is not likely to be any risk to health. the system will stop processing samples if a mechanical jam occurs.
  • Action
    Siemens will inspect all systems for the defect on the next service visit. In the interim users are requested to contact Siemens Technical Support should an Error [465] or [302] occur. This action has been closed-out on 03/03/2016.

Device

IMMULITE® 2000 IMMULITE® 2000 XPi Immunoassay System. An in vitro diagnostic medical device (IVD)...
  • Model / Serial
    IMMULITE® 2000 IMMULITE® 2000 XPi Immunoassay System. An in vitro diagnostic medical device (IVD)Reagent Carousel Temperature Sensor Printed Circuit Board (PCB) Assembly ARTG number: 174399
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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