Events

Recall of Immulite (all systems) - Sample Cup Holders and Microsample Inserts. In vitro diagnostic medical devices (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-2015-RN-00520-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00520-1
  • 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 conductive material of the sample cup holders and microsample inserts, which are used to process samples, do not meet specification for facilitating sample level sensing. when sample level sensing is compromised, sample will not be pipetted and the test or tests ordered for the sample will not be run.
  • Action
    This issue has been corrected for future lots of sample cup holders and microsample inserts. Siemens is requesting laboratories to cease using the faulty sample cup holders and microsample inserts until unaffected sample receptacles are received.

Device

Immulite (all systems) - Sample Cup Holders and Microsample Inserts. In vitro diagnostic medical ...
  • Model / Serial
    Immulite (all systems) - Sample Cup Holders and Microsample Inserts. In vitro diagnostic medical devices (IVD)Sample Cup Holder used on Immulite/Immulite 1000 SystemsSiemens Material Number: 10385360 (Set 1-50)Lot number: 15, 16Microsample Insert used on Immulite 2000 / 2000 Xpi SystemsSiemens Material Number: 10385209 (Set of 15)Lot number: 18, 19, 20ARTG Number: 174399
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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