Test Thrombin Reagent 10446598Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842768012716), received between Sep 6, 2023 and Oct 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT HIGHER THROMBIN TIME (TT) RESULTS WERE OBTAINED ON FIVE PATIENT SAMPLES ON A SYSMEX CS-5100 SYSTEM USING TEST THROMBIN REAGENT LOT 02056, COMPARED TO THE RECOVERIES FROM AN ALTERNATE SYSMEX CS-5100 SYSTEM USING TEST THROMBIN REAGENT LOT 01552. THE CUSTOMER INDICATED THAT THE LOWER TT RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT TT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996820 ↗
• MalfunctionSep 6, 2023Low Test Results; Low Test Results

  THREE FALSELY DEPRESSED THROMBIN TIME (TT) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON TWO SYSMEX CS-5100 SYSTEMS USING TEST THROMBIN REAGENT. WHEN THE SAMPLE WAS PROCESSED INITIALLY ON THE SYSMEX CS-5100 SYSTEM (SERIAL NUMBER:(B)(6), THE SAMPLE RECOVERED HIGHER. THE INITIAL HIGHER TT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW TT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695271 ↗