Dade Actin FSL Activated PTT ReagentRecalls & reported problems across all models

We found 2 models of Dade Actin FSL Activated PTT Reagent by Siemens Healthcare Diagnostics Products GmbH in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Aug 11, 2017 and May 15, 2026 — classified as 38 malfunctions.

The most frequently reported specific device problem is “High Test Results” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Dade Actin FSL Activated PTT Reagent problems

Dade Actin FSL Activated PTT Reagent models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Dade® Actin® FSL Activated PTT Reagent 10445714

  TEST, TIME, PARTIAL THROMBOPLASTIN
  32 reports
• Dade® Actin® FSL Activated PTT Reagent 10445713

  TEST, TIME, PARTIAL THROMBOPLASTIN
  6 reports

Recent Dade Actin FSL Activated PTT Reagent adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Low Test Results

  THE CUSTOMER REPORTED A FLAGGED APTT (ACTIVATED PARTIAL THROMBOPLASTIN TIME) RESULT OBTAINED ON A PATIENT SAMPLE ON CS-2500 INSTRUMENT. THE FLAGGED RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE PATIENT RESULT, AND THE LABORATORY REPEATED THE MEASUREMENT ON AN ALTERNATE INSTRUMENT. THE REPEAT RESULT WAS LONGER THAN THE ERRONEOUS REPORTED RESULT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS REPORTED APTT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25180610 ↗
• MalfunctionNov 10, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED APTT (ACTIVATED PARTIAL THROMBOPLASTIN TIME) RESULTS OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH DADE ACTIN FSL ACTIVATED PTT REAGENT ON A SYSMEX CS-2500 SYSTEM COMPARED TO THE REPEATED RESULTS. THE ERRONEOUS RESULT WAS INITIALLY REPORTED TO THE PHYSICIAN BUT CORRECTED BY THE LOWER REPEATED RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THESE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511211 ↗
• MalfunctionNov 10, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED APTT (ACTIVATED PARTIAL THROMBOPLASTIN TIME) RESULTS OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH DADE ACTIN FSL ACTIVATED PTT REAGENT ON A SYSMEX CS-2500 SYSTEM COMPARED TO THE REPEATED RESULTS. THE ERRONEOUS RESULT WAS INITIALLY REPORTED TO THE PHYSICIAN, BUT CORRECTED BY THE LOWER REPEATED RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THESE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511209 ↗
• MalfunctionSep 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED APTT (ACTIVATED PARTIAL THROMBOPLASTIN TIME) SEC RESULT OBTAINED ON A PATIENT SAMPLE MEASURED WITH DADE ACTIN FSL ACTIVATED PTT REAGENT ON THE CS-5100 INSTRUMENT, COMPARED TO REPEAT RESULT. THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO DID NOT QUESTION THE RESULT. THE LAB AUTOVERIFIED THE RESULT AND PROVIDED A CORRECTED REPORT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036703 ↗
• MalfunctionSep 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED APTT (ACTIVATED PARTIAL THROMBOPLASTIN TIME) SEC RESULT OBTAINED ON A PATIENT SAMPLE MEASURED WITH DADE ACTIN FSL ACTIVATED PTT REAGENT ON THE CS-5100 INSTRUMENT, COMPARED TO REPEAT RESULT. THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO DID NOT QUESTION THE RESULT. THE LAB AUTOVERIFIED THE RESULT AND PROVIDED A CORRECTED REPORT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036672 ↗
• MalfunctionSep 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED APTT (ACTIVATED PARTIAL THROMBOPLASTIN TIME) SEC RESULT OBTAINED ON A PATIENT SAMPLE MEASURED WITH DADE ACTIN FSL ACTIVATED PTT REAGENT ON THE CS-5100 INSTRUMENT, COMPARED TO REPEAT RESULT. THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO DID NOT QUESTION THE RESULT. THE LAB AUTOVERIFIED THE RESULT AND PROVIDED A CORRECTED REPORT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036656 ↗
• MalfunctionSep 23, 2024Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT MEASURED WITH THE DADE® ACTIN® FSL ACTIVATED PTT REAGENT ON A SYSMEX CS-2500 SYSTEM. THE ERRONEOUS RESULT WAS FLAGGED WITH TWO ERROR CODES AND WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS ADMINISTERED 5000 I/U HEPARIN WHICH WAS LATER DETERMINED TO HAVE BEEN UNNECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279006 ↗
• MalfunctionAug 13, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT MEASURED WITH THE DADE® ACTIN® FSL ACTIVATED PTT REAGENT ON A SYSMEX CS-2500 SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULT. THE REPEAT 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 ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974110 ↗
• MalfunctionFeb 19, 2024High Test Results; High Test Results

  THREE FALSELY ELEVATED FACTOR XI RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM USING DADE ACTIN FSL ACTIVATED PTT REAGENT. THE SAMPLE WAS THEN REPEATED THREE ADDITIONAL TIMES AND THE RESULTS RECOVERED LOWER. TWO DAYS LATER, A NEW SAMPLE FROM THE PATIENT WAS COLLECTED AND WAS RUN FOR FACTOR XI THREE TIMES, EACH TIME RECOVERING FALSELY ELEVATED. THE ELEVATED FACTOR XI RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE PHYSICIAN(S) QUESTIONED THE RESULT. THREE DAYS LATER, THE SAMPLE WAS RERUN FOR FACTOR XI THREE TIMES, AND RECOVERED LOWER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS FACTOR XI RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730703 ↗
• MalfunctionFeb 19, 2024High Test Results; High Test Results

  THREE FALSELY ELEVATED FACTOR XI RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM USING DADE ACTIN FSL ACTIVATED PTT REAGENT. THE SAMPLE WAS THEN REPEATED THREE ADDITIONAL TIMES AND THE RESULTS RECOVERED LOWER. TWO DAYS LATER, A NEW SAMPLE FROM THE PATIENT WAS COLLECTED AND WAS RUN FOR FACTOR XI THREE TIMES, EACH TIME RECOVERING FALSELY ELEVATED. THE ELEVATED FACTOR XI RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE PHYSICIAN(S) QUESTIONED THE RESULT. THREE DAYS LATER, THE SAMPLE WAS RERUN FOR FACTOR XI THREE TIMES, AND RECOVERED LOWER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS FACTOR XI RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730688 ↗
• MalfunctionFeb 25, 2022Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES FROM FOUR DIFFERENT PATIENTS ON A BCS XP SYSTEM USING DADE ACTIN FSL ACTIVATED PTT REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAMPLES WERE REPEATED FOR APTT ON AN ALTERNATE BCS XP SYSTEM, RECOVERING HIGHER. THE HIGHER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). ONE OF THE FOUR PATIENTS HAD A NEW SAMPLE DRAWN WHICH WAS RUN FOR APTT ON THE ALTERNATE BCS XP, MATCHING THE HIGHER REPEAT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT APTT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599193 ↗
• MalfunctionOct 12, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-660 SYSTEM USING DADE ACTIN FSL APTT REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT'S HEPARIN DOSE WAS ADJUSTED DUE TO THE LOW APTT RESULT. THE SAMPLE WAS REPEATED THREE HOURS LATER FOR APTT, RECOVERING HIGHER. THE HIGHER RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). ANOTHER SAMPLE FROM THIS PATIENT HAD BEEN TESTED EARLIER IN THE MORNING FOR APTT AND HAD ALSO RECOVERED HIGHER AND BEEN REPORTED TO THE PHYSICIAN(S). LATER THAT NIGHT, A NEW SAMPLE FROM THE PATIENT WAS DRAWN AFTER THE PATIENT'S HEPARIN DOSE WAS ADJUSTED. THE SAMPLE WAS RUN FOR APTT, RECOVERING HIGHER. THIS RESULT WAS ALSO REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) OR THE CHANGE IN HEPARIN DOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12615396 ↗
• MalfunctionAug 26, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-2500 SYSTEM USING DADE ACTIN FSL ACTIVATED PTT REAGENT. THE RESULT WAS FLAGGED WITH ASTERISKS. THE SAMPLE WAS TESTED AGAIN FOR APTT USING A TILT TUBE, WHICH ALSO RECOVERED FALSELY LOW. THE FALSELY LOW APTT RESULT OBTAINED USING THE TILT TUBE WAS REPORTED TO THE PHYSICIAN(S). AFTER THE LOW RESULT WAS REPORTED, THE PATIENT RECEIVED A HEPARIN BOLUS AND STARTED TO BLEED. A CAT SCAN WAS ALSO PERFORMED ON THE PATIENT DUE TO THE EXTRA HEPARIN ADMINISTRATION. THE SAME SAMPLE WAS REPEATED AGAIN FOR APTT LATER THE SAME DAY USING ANOTHER TILT TUBE, RECOVERING HIGHER. THIS RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THE FOLLOWING DAY, THE PATIENT WAS REDRAWN AND THE SAMPLE WAS RUN FOR APTT TWO TIMES ON THE SYSMEX CS-2500 SYSTEM USING DADE ACTIN FSL ACTIVATED PTT REAGENT. THE INITIAL RUN GAVE AN EARLY REACTION ERROR AND DID NOT GIVE NUMERIC RESULTS. THE SECOND RUN GAVE AN APTT RESULT WHICH MATCHED THE HIGHER RESULT FROM THE DAY BEFORE. THE HIGHER RESULT WAS CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12372747 ↗
• MalfunctionJan 19, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  A CUSTOMER SCRAPED THEIR FINGER WHILE OPENING A VIAL OF DADE ACTIN FSL ACTIVATED PTT REAGENT. THE CUSTOMER DISINFECTED AND BANDAGED THE WOUND. NO MEDICAL INTERVENTION WAS REQUIRED BEYOND FIRST AID. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11195983 ↗
• MalfunctionNov 24, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON SIX PATIENT SAMPLES ON A SYSMEX CA-660 SYSTEM USING DADE ACTIN FSL ACTIVATED PTT REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REFRIGERATED AND RERUN THE FOLLOWING DAY FOR APTT, AS THE CUSTOMER WAS QUESTIONING THE RESULTS. THE REPEATED SAMPLES RECOVERED LOWER. THESE REPEAT RESULTS WERE CONSIDERED TO BE THE CORRECT RESULTS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10896329 ↗

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