Events

Recall of Stratus CS Acute Care Diagnostics System. 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-00867-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-06-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00867-1
  • 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 has identified a software defect in the stratus cs acute care diagnostics system regarding testpak calibration and quality control (qc) status when a testpak is due to expire within 48 hours. depending on the calibration status, either an above assay range (aar) or an inaccurate value could potentially be reported when running a testpak that is due to expire within 48 hours. the probability of occurrence is extremely unlikely and other factors such as previous results, patient presentation, and other diagnostic testing would initiate clinical questioning and reduce the potential for injury.
  • Action
    Siemens Healthcare is advising users of the following: 1. Do not use TestPaks that are due to expire within 48 hours, OR 2. Check Reagent Status to ensure all TestPaks in use have valid calibration expiry dates beyond the TestPak lot expiry date, AND 3. If the laboratory performs routine QC and if using a TestPak that is due to expire within 48 hours, ensure that scheduled QC is performed before running a test. Siemens Healthcare is currently developing software updates to address this issue and will be providing new information as it becomes available.

Device

Stratus CS Acute Care Diagnostics System. An in vitro diagnostic medical device (IVD).

Manufacturer

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