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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00867-1
Product Name/Description Stratus CS Acute Care Diagnostics System. An in vitro diagnostic medical device (IVD)

Siemens Material Numbers: 10444834, 10453531, 10453570, 10453571, 10470384

All Software versions

All Serial Numbers

ARTG Number: 174699
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 29/06/2016
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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.

This action has been closed out on 09/07/2019
Contact Information 1800 310 300 - Siemens Technical Support Centre