Dade® Thrombin Reagent 10445720Recalls & reported problems
Siemens Healthcare Diagnostics Products GmbH · Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies · Class 2
Data updated Oct 16, 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 00842768003943), received between Oct 23, 2024 and Oct 23, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
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.
MalfunctionOct 23, 2024Use of Device Problem; Use of Device Problem
THE CUSTOMER REPORTED THE OBSERVATION OF NON-NUMERIC, FLAGGED, PATIENT RESULTS MEASURED WITH THE DADE THROMBIN REAGENT ON A SYSMEX CS-2500 INSTRUMENT. THE CUSTOMER USED THE CALIBRATION CURVE TO ESTIMATE A RESULT OF 2.14 G/L AND THIS WAS REPORTED TO, AND NOT QUESTIONED BY, THE PHYSICIAN(S).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20513198 ↗
Other SYSTEM, FIBRINOGEN DETERMINATION devices
- STA® - Fibrinogen 5 00674Diagnostica Stago · SYSTEM, FIBRINOGEN DETERMINATION1 recall0 reports
- Dade® Owren's Veronal Buffer 10445724Siemens Healthcare Diagnostics Products GmbH · SYSTEM, FIBRINOGEN DETERMINATION1 report
- Dade® Thrombin Reagent 10445721Siemens Healthcare Diagnostics Products GmbH · SYSTEM, FIBRINOGEN DETERMINATION1 report
- Multifibren® U 10446691Siemens Healthcare Diagnostics Products GmbH · SYSTEM, FIBRINOGEN DETERMINATION1 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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