Events

Recall of VersaCell connected to IMMULITE 2000/IMMULITE 2000 XPi analysers

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-00137-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00137-1
  • 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
    There is a potential for incorrect results to be reported when the versacell system drops a sample tube during transfer to the immulite 2000/immulite 2000 xpi automation rack under certain specific conditions. this issue only occurs with versacell systems that are connected to immulite 2000/2000xpi and does not affect any other analysers that interface with the versacell system.
  • Action
    Siemens is providing additional instructions to mitigate the occurrence of incorrect results due to dropped tubes. Investigations into the issue are continuing and customers will be alerted once a solution has been developed. This action has been closed-out on 04/04/2017.

Device

VersaCell connected to IMMULITE 2000/IMMULITE 2000 XPi analysers

Manufacturer

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