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STRATUS CS SYSTEMS (2016-06-23)
- Starting date:
- June 23, 2016
- Posting date:
- June 30, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, Hospitals, General Public
- Identification number:
- RA-59128
Affected products
A. STRATUS CS ACUTE CARE SYSTEM - FLOUROMETRIC ANALYZER
B. STRATUS CS 200
Reason
Siemens Healthcare has confirmed a software defect in the Stratus CS Acute Care Diagnostics System and Stratus CS 200 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.
Affected products
A. STRATUS CS ACUTE CARE SYSTEM - FLOUROMETRIC
Lot or serial number
All lots
Model or catalog number
758000.901
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark, Delaware
19714-6101
UNITED STATES
ANALYZER B. STRATUS CS 200
Lot or serial number
All lots
Model or catalog number
10714016
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark, Delaware
19714-6101
UNITED STATES