Protein C Reagent 10446185Recalls & reported problems
Siemens Healthcare Diagnostics Products GmbH · Coagulation test for the quantitative determination of protein C activity in human plasma · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842768008641), received between Dec 4, 2025 and Dec 10, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED PROTEIN C RESULT OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH PROTEIN C REAGENT ON THE CN-6000 INSTRUMENT COMPARED TO AN ALTERNATE METHOD. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23766735 ↗MalfunctionDec 4, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED PROTEIN C RESULT OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH PROTEIN C REAGENT ON THE CN-6000 INSTRUMENT COMPARED TO AN ALTERNATE METHOD. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715281 ↗
Other TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY devices
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- STA® - Staclot® Protein S 00746Diagnostica Stago · TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY1 recall0 reports
- Factor VIII Chromogenic Assay 10445729Siemens Healthcare Diagnostics Products GmbH · TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY6 reports
- Berichrom® Protein C 10446499Siemens Healthcare Diagnostics Products GmbH · TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY2 reports
- Factor VIII Antibody Screen F8SImmucor Gti Diagnostics, Inc. · Test, Qualitative And Quantitative Factor Deficiency1 report
- Protein S Ac 10445968Siemens Healthcare Diagnostics Products GmbH · TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY1 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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