Protein S Ac 10445968Recalls & reported problems
Siemens Healthcare Diagnostics Products GmbH · Determination of the functional activity of protein S in human plasma · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768006678), received between May 1, 2025 and May 1, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2025Low Test Results; Low Test Results
THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY DEPRESSED PROTEIN S AC RESULTS COMPARED TO REPEAT TESTING FOR MULTIPLE PATIENT SAMPLES USING LOT 03229 ON A BCS XP INSTRUMENT. THE FALSELY DEPRESSED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED PROTEIN S AC RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21941319 ↗
Other TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY devices
- STA® - Liatest® Free Protein S 6 00516Diagnostica Stago · TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY1 recall0 reports
- 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
- Protein C Reagent 10446185Siemens Healthcare Diagnostics Products GmbH · TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY2 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
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 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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