Events

Recall of CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems

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-01062-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01062-1
  • 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 healthcare diagnostics has received customer complaints regarding damage to the external power supply adaptors that accompany the clinitek status, clinitek status+, and clinitek status connect urine analysers, which can result in an increased potential for electric shock to the user. this also includes orderable spare parts.
  • Action
    If the power supply adaptor is embossed with one of the affected date codes, immediately discontinue use and discard the power supply adaptor. If your power supply adaptor does not have an affected date code, but the case is cracked or damaged in any way, immediately discontinue use and discard the power supply adaptor. This action has been closed-out on 07/06/2016.

Device

CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems
  • Model / Serial
    CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect SystemsMultiple Siemens Material Numbers and Date Codes affectedARTG Number: 175890
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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