Siemens Stratus CS Acute Care Cardiac Troponin Test Recalled for False Positives
Siemens Healthcare Diagnostics is recalling the Stratus CS Acute Care cTNI TestPak, a cardiac troponin test, due to increased false positive results that could affect patient diagnosis.
What this means for you
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: This FDA Class II recall involves a diagnostic test with documented false positive results that could affect clinical decision-making. No illnesses, injuries, or deaths have been reported, limiting the score to a maximum of 3 per the rubric.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling the Stratus CS Acute Care cTNI TestPak, an in vitro diagnostic test for cardiac troponin I in heparinized plasma, used to measure cardiac troponin I levels in blood samples.
The recall was issued due to an increased occurrence of random false positive results for cardiac troponin I. These false positive results may occur at any point during the product's shelf life and are non-repeatable—retesting may not reproduce the initial result. False positive results could lead to incorrect clinical decisions based on inaccurate test findings.
A total of 367 units were distributed worldwide. Within the United States, the product was distributed to California, Illinois, Kansas, Michigan, Missouri, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, and Wisconsin. The product was also distributed internationally to Austria, Canada, Chile, France, Germany, Iraq, Italy, Malaysia, North Macedonia, Saudi Arabia, Serbia, Slovenia, Spain, Sweden, Switzerland, and Vietnam. The affected lot numbers are 234337002 and forward (Siemens Materials No. 10445071; UDI-DI: 0405686902174VK).
The recalled product
- Product
- Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- false-positive
- diagnostic-error
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 (3)
- Siemens Materials No. 10445071
- UDI-DI: 0405686902174VK
- Lot No. 234337002 and forward.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03