Events

Recall of EZee-Nest Insert Cups used with ADVIA Centaur CP. 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-00389-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00389-1
  • 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 an issue with use of the ezee-nest insert cups due to 2 inaccuracies that exist in the advia centaur cp operator’s guide, appendix d, pre-set tube types. the 1st inaccuracy refers to the sample volume supported by the system when using the ezee-nest cup to process samples. the operator's guide states that sample volumes greater than 50ul can be used; however volumes greater than 150ul cannot be used when using an ezee-nest insert cup. the 2nd inaccuracy refers to the use of the universal cup adaptor with an ezee-nest insert cup in 65-mm sample racks. siemens has determined that the height of an ezee-nest insert cup with universal cup adaptor fitted on a 65-mm sample rack will not fit into the sample compartment. there is no impact on patient samples as a result of these issues. there is the potential for loss of aspirated sample (up to 250 ìl including the dead volume in the insert cup) & a delay in providing patient test results due to this issue.
  • Action
    Siemens is advising users to not use EZee-Nest Insert Cups with assays that require sample volumes greater than 150µL or the Universal Cup Adapter with the EZnee-Nest insert cups in 65mm sample racks. Users should instead use the Siemens Sample cup along with the required 100mm sample rack and 100mm Siemens cup Tube Setting for assays that require sample volumes larger than 150µL.

Device

EZee-Nest Insert Cups used with ADVIA Centaur CP. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    EZee-Nest Insert Cups used with ADVIA Centaur CP. An in vitro diagnostic medical device (IVD)Siemens Material Number (SMN): 10309710ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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