Stratus® CS 10444834Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · The Stratus® CS STAT Fluorometric Analyzer is a microprocessor controlled instrument that measures analytes in body fluids for in vitro diagnostic use. The instrument is intended for use by trained healthcare professionals in the clinical laboratory and point of care settings and is intended for the measurement of the following analytes: High Sensitivity Troponin-I (CTNI), CK-MB Mass (Creatine kinase. MB) (CKMB), Myoglobin (MYO), NT-proBNP (PBNP), D-dimer (DDMR), CardioPhase hsCRP (High Sensitiv · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
The Stratus CS is a Siemens laboratory analyzer that measures heart and clotting markers such as troponin, CK-MB, myoglobin and D-dimer in blood samples. The 71 reports mostly describe troponin results that came back positive when repeat testing on the same or another analyzer did not reproduce them, along with a few results that could not be repeated and some unusually high readings. No deaths and no injuries were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00842768024863), received between Dec 6, 2017 and Mar 10, 2026 — classified as 71 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (56 reports).
3 other recalls cover devices cleared under the same FDA submission (K984067); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- False Positive Result56
- Non Reproducible Results6
- Insufficient Device Problem Information4
- False Negative Result3
- Device Operates Differently Than Expected2
- High Test Results2
- Device Displays Incorrect Message1
- Electrical /Electronic Property Problem1
Patient problems
- No Consequences Or Impact To Patient26
- No Clinical Signs, Symptoms or Conditions22
- No Known Impact Or Consequence To Patient17
- Insufficient Information3
- No Patient Involvement3
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026False Positive Result
THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSE POSITIVE TROPONIN (CTNI) RESULT COMPARED TO RETESTING ON THE SAME DEVICE AND ALSO THEIR LABORATORY INSTRUMENT. THE CONTROLS WERE PASSING. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24559427 ↗MalfunctionAug 15, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSE POSITIVE TROPONIN (CTNI) RESULT COMPARED TO REPEAT TESTING OF THE SAME SAMPLE ON THE SAME INSTRUMENT. CUSTOMER NOTES THAT THEY DID NOT MEET THEIR 30 MIN TURNAROUND TIME BETWEEN COLLECTION AND TESTING. FURTHER COMPARATIVE TESTING WAS PERFORMED ON THEIR LAB INSTRUMENT, HOWEVER RESULTS WERE NOT PROVIDED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19996286 ↗MalfunctionJun 26, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSE POSITIVE TROPONIN (CTNI) RESULT COMPARED TO RETESTING OF A DIFFERENT SAMPLE ON THEIR LABORATORY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19613473 ↗MalfunctionJun 4, 2024False Positive Result; False Positive Result
CUSTOMER REPORTED THAT THEIR STRATUS CS PRODUCED A FALSE POSITIVE TOPONIN (CTNI) RESULT. ALTHOUGH A FALSE POSITIVE CTNI RESULTS WERE ALLEGED THE CUSTOMER HAS NOT PROVIDED THE TRUE OR EXPECTED RESULT FOR COMPARISON. INITIAL RESULT OF 0.10 NG/ML WAS GENERATED AND REPEAT THE WAS 0.14 NG/ML. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19458480 ↗MalfunctionMay 23, 2024False Positive Result; False Positive Result
CUSTOMER REPORTED THAT THEIR STRATUS CS INSTRUMENT PRODUCED A FALSE POSITIVE TROPONIN (CTNI) RESULTS COMPARED TO REPEAT ANALYSIS ON THE SAME ANALYZER THE CUSTOMER VERIFIED THAT THAT THE FALSE POSITIVE WAS NOT REPORTED TO THE PHYSICIAN. PER THEIR LAB PROCEDURES ALL POSITIVE TROPONINS ARE REPEATED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19380773 ↗MalfunctionApr 22, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED THAT THEIR STRATUS CS INSTRUMENT PRODUCED TWO FALSE POSITIVE CTNI (TROPONIN) RESULTS ON ONE PATIENT COMPARED TO RETESTING OF THE SAME SAMPLE ON TWO OTHER LAB INSTRUMENTS. THE CUSTOMER IS ALSO RUNNING A DAILY PLASMA POOL ACROSS ALL ANALYZERS, AND THEY HAVE SEEN LARGE DEVIATIONS WITH THIS LOW CONTROL. FOUR NEW REPEATS OF THE QC HAVE BEEN RUN WITH GOOD RESULTS, AND THE CUSTOMER WILL CONTINUE RUNNING PATIENT SAMPLES IN PARALLEL. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19154472 ↗MalfunctionApr 15, 2024Device Displays Incorrect Message; Device Displays Incorrect Message
THE CUSTOMER REPORTED THAT THEIR STRATUS CS INSTRUMENT PRODUCED A FALSE POSITIVE TROPONIN (CTNI) RESULT COMPARED TO RETESTING OF THE SAME SAMPLE ON THEIR LABORATORY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19110926 ↗MalfunctionApr 15, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED THAT THEIR STRATUS CS INSTRUMENT PRODUCED A FALSE POSITIVE TROPONIN (CTNI) RESULT ON ONE PATIENT COMPARED TO RETESTING OF THE SAME SAMPLE ON THEIR LABORATORY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19110483 ↗MalfunctionApr 15, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED THAT THEIR STRATUS CS INSTRUMENT PRODUCED A FALSE POSITIVE TROPONIN (CTNI) RESULT COMPARED TO RETESTING OF THE SAME SAMPLE ON THEIR LABORATORY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19109142 ↗MalfunctionApr 15, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED THAT THEIR STRATUS CS INSTRUMENT PRODUCED A FALSE POSITIVE TROPONIN (CTNI) RESULT ON ONE PATIENT COMPARED TO RETESTING OF THE SAME SAMPLE ON ANOTHER STRATUS CS INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19107972 ↗MalfunctionMar 27, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSE POSITIVE TROPONIN RESULT ON ONE PATIENT COMPARED TO RETESTING OF THE SAME SAMPLE ON THE SAME INSTRUMENT AND THEIR LABORATORY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18988899 ↗MalfunctionFeb 28, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED THAT THEIR STRATUS CS INSTRUMENT GAVE A FALSE POSITIVE TROPONIN (CTNI) RESULT COMPARED TO REPEAT TESTING OF THE SAME SAMPLE ON THE SAME INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18797827 ↗MalfunctionFeb 14, 2024False Positive Result; False Positive Result
CUSTOMER REPORTED THAT THEIR STRATUS CS INSTRUMENT GAVE A FALSE POSITIVE TROPONIN RESULT. CUSTOMER REPEATED THE SAME SAMPLE ON THE SAME ANALYZER AND RECEIVED A NEGATIVE RESULT WHICH THE CUSTOMER BELIEVED TO BE TRUE. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18702611 ↗MalfunctionFeb 9, 2024False Positive Result; False Positive Result
CUSTOMER REPORTED THAT THEIR STRATUS CS INSTRUMENT GAVE A FALSE POSITIVE CTNI RESULT. CUSTOMER PERFORMED REPEAT ANALYSIS ON THE SAME INSTRUMENT. THE REPEATED PATIENT RESULTS WERE ALL NEGATIVE AND THE QC WAS PASSING. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18675875 ↗MalfunctionFeb 8, 2024False Positive Result; False Positive Result
CUSTOMER REPORTED THAT THEIR STRATUS CS INSTRUMENT GAVE A FALSE POSITIVE CTNI RESULT. CUSTOMER PERFORMED REPEAT ANALYSIS ON THE SAME INSTRUMENT. THE REPEATED PATIENT RESULTS WERE ALL NEGATIVE AND THE QC WAS PASSING. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18672218 ↗MalfunctionNov 16, 2023False Positive Result; False Positive Result
CUSTOMER REPORTED THAT THEIR STRATUS CS INSTRUMENT GAVE A FALSE POSITIVE CTNI RESULT COMPARED TO RETESTING OF THE SAME SAMPLE ON THE SAME INSTRUMENT SEVERAL MINUTES APART. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18151485 ↗MalfunctionOct 4, 2023False Positive Result; False Positive Result
CUSTOMER REPORTED THAT THEIR STRATUS CS INSTRUMENT GAVE A FALSE POSITIVE CTNI RESULT COMPARED TO RETESTING OF THE SAME SAMPLE ON THE SAME INSTRUMENT SEVERAL HOURS APART.THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17868084 ↗MalfunctionDec 29, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED THAT THEIR STRATUS CS INSTRUMENT PROVIDED A FALSE POSITIVE TROPONIN RESULT COMPARED TO RETESTING OF THE SAME SAMPLE ON THE SAME INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16067244 ↗MalfunctionSep 6, 2022High Test Results; High Test Results
THE CUSTOMER REPORTED THAT THEY RECEIVED A DISCREPANT HIGH CTNI (TROPONIN) RESULT COMPARED TO REPEAT TESTING OF THE SAME SAMPLE ON THE SAME INSTRUMENT AND NEW SAMPLES ON OTHER NON-SIEMENS DEVICES. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15365172 ↗MalfunctionJun 28, 2022High Test Results; High Test Results
THE CUSTOMER REPORTED THAT THEY RECEIVED A DISCREPANT HIGH CTNI (TROPONIN) RESULT COMPARED TO REPEAT TESTING OF THE SAME SAMPLE AND A NEW SAMPLE ON THE SAME INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14846595 ↗MalfunctionApr 1, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED A FALSE POSITIVE TROPONIN RESULT ON THEIR STRATUS SC INSTRUMENT COMPARED TO REPEAT TESTING OF THE SAME SAMPLE ON THE SAME INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13980575 ↗MalfunctionDec 22, 2021False Positive Result; False Positive Result
THE CUSTOMER REPORTED A FALSE POSITIVE CARDIAC TROPONIN FOR ONE PATIENT ON THE CARDIAC SCS COMPARED TO TWO REPEATS WHICH WERE NEGATIVE. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13063728 ↗MalfunctionOct 29, 2021False Positive Result; False Positive Result
THE CUSTOMER REPORTED A FALSE POSITIVE TROPONIN RESULT FOR ONE PATIENT ON THEIR CARDIAC SCS INSTRUMENT COMPARED TO REPEATED NEGATIVE RESULTS ON THE SAME INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 12724027 ↗MalfunctionOct 25, 2021False Positive Result; False Positive Result
THE CUSTOMER REPORTED THAT TWO PATIENTS HAD FALSE POSITIVE TROPONIN RESULTS ON THE STRATUS CS. VERY LIMITED INFORMATION HAS BEEN PROVIDED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION BE PROVIDED SEVERAL TIMES.
Patient problems: Insufficient Information
MAUDE report 12689701 ↗MalfunctionOct 7, 2020Non Reproducible Results; Non Reproducible Results
THE CUSTOMER REPORTED A DISCREPANT LOW D-DIMER RESULT ON THE STRATUS CS ANALYZER WHEN COMPARED TO A NON-SIEMENS LAB ANALYZER. THE CUSTOMER STATED AN ULTRASOUND SCAN WAS DELAYED BY ONE DAY. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 10642352 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K984067. One submission often covers many models, so check the product and lot details in each record.
- Z-2525-2016 · Jun 22, 2016 · TerminatedStratus CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB
- Z-0343-2011 · Dec 7, 2009 · TerminatedStratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09 Intended use: Stratus(R) rotors is intended for the separation of whole blood samples for analysis on the Stratu
- Z-0875-06 · Apr 3, 2006 · TerminatedStratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic.
Other FLUOROMETRIC METHOD, CPK OR ISOENZYMES devices
- VITROS 1896836Ortho Clinical Diagnostics · FLUOROMETRIC METHOD, CPK OR ISOENZYMES4 reports
- Access CK-MB 386371Beckman Coulter, Inc. · Fluorometric Method, Cpk Or Isoenzymes1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page