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

Recall

RC-2016-RN-00867-1

Class I

2016-06-29

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00867-1

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.

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.