Dade® Thrombin Reagent 10445721Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768003950), received between Jul 25, 2024 and Jul 25, 2024 — 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY DEPRESSED FIBRINOGEN RESULTS ON ONE PATIENT MEASURED WITH THE SIEMENS DADE THROMBIN REAGENT ON A SYSMEX CS-5100 SYSTEM (LEGAL MANUFACTURER: SYSMEX) COMPARED TO THE HISTORICAL FIBRINOGEN RESULTS OBTAINED ON AN ALTERNATE METHOD. THE PATIENT SAMPLE WAS PROCESSED IN 1:1 AND 4:1 DILUTIONS. FOR BOTH DILUTION RESULTS, THE INSTRUMENT GENERATED A FLAG AND DID NOT DISPLAY NUMERICAL RESULTS. HOWEVER, THE USER IGNORED OR MISINTERPRETED THE MESSAGE OR FLAG AND REPORTED THE RESULTS (AS <0.3 G/L) TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED FIBRINOGEN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826720 ↗