Siemens Stratus CS STAT Fluorometric Analyzer Software Defect Recall
Siemens is recalling Stratus CS STAT Fluorometric Analyzers due to a software defect that may cause inaccurate test results or out-of-range values when TestPaks are near expiration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a software defect that can lead to inaccurate diagnostic results. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it is not an FDA Class I recall.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 977 units of the Stratus CS STAT Fluorometric Analyzer. This microprocessor-controlled instrument is used for in vitro diagnostic testing to measure specific analytes in body fluids, including assays for hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. The recall covers all software versions and serial numbers.
The recall is due to a software defect related to TestPak calibration and quality control (QC) status. Specifically, when a TestPak is due to expire within 48 hours, the system may report an 'Above Assay Range' result or an inaccurate value. This defect could potentially lead to incorrect diagnostic information.
The affected units were distributed worldwide, including in the United States, Canada, and numerous countries across Europe, Asia, Africa, and the Middle East. Users of these instruments should contact Siemens Healthcare Diagnostics Inc for instructions on how to resolve the software defect.
The recalled product
- Product
- Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 977
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All software versions and serial numbers
Distribution
Distribution scope not specified by the agency.
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