Dade® Actin® FSL Activated PTT Reagent 10445714Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00842768003882), received between Aug 11, 2017 and May 15, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “High Test Results” (12 reports).

2 other recalls cover devices cleared under the same FDA submission (K863594); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, 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 ↗
• MalfunctionNov 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER HAS REPORTED THAT THEIR LAB HAD FAILED THREE AMERICAN PROFICIENCY INSTITUTE (API) SURVEYS FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) ON A SYSMEX CA-620 SYSTEM USING DADE ACTIN FSL ACTIVATED PTT REAGENT. DUE TO FAILING THREE SURVEYS, THE CUSTOMER HAS HAD TO SEND SAMPLES OUT TO AN ALTERNATE LAB TO BE TESTED FOR APTT. IT IS UNKNOWN IF ANY DISCORDANT PATIENT APTT RESULTS HAVE BEEN OBTAINED DUE TO THIS ISSUE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEATH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10777961 ↗
• MalfunctionOct 30, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED 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 DISCORDANT RESULT WAS FLAGGED WITH AN ANALYSIS OVER TIME FLAG. THE SAMPLE WAS AUTO-REPEATED FOR APTT, ALSO RECOVERING FALSELY ELEVATED. THE SAMPLE WAS RE-SPUN DUE TO THE HIGH RESULTS AND WAS REPEATED FOR APTT USING THE SAME SYSTEM AND REAGENT, RECOVERING LOWER. THIS LOWER RESULT WAS FLAGGED WITH A DEFECTIVE SAMPLE VOLUME ERROR. THE SAME SAMPLE WAS THEN REPEATED ON AN ALTERNATE SYSMEX CS-2500 SYSTEM USING DADE ACTIN FSL ACTIVATED PTT REAGENT, RECOVERING LOWER WITH NO FLAGS. THIS RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). 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 10766778 ↗
• MalfunctionAug 12, 2019Off-Label Use; Low Test Results; Off-Label Use; Low Test Results

  A DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM SERIAL NUMBER: (B)(4) USING DADE ACTIN FSL ACTIVATED PTT REAGENT (LOT NUMBER: 556936). THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER LATER QUESTIONED THE INITIAL RESULT. THE ORIGINAL PATIENT SAMPLE WAS REPEATED FOR APTT TWICE USING THE SAME BCS XP SYSTEM SERIAL NUMBER: (B)(4), RESULTING HIGHER. THE SAME SAMPLE WAS THEN REPEATED FOR APTT TWICE USING AN ALTERNATE BCS XP SYSTEM SERIAL NUMBER: (B)(4), RESULTING HIGHER AND CONFIRMING THE REPEAT RESULTS FROM THE FIRST BCS XP SYSTEM SERIAL NUMBER: (B)(4). THE REPEAT RESULTS FROM BCS XP SYSTEM SERIAL NUMBER: (B)(4) WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW APTT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8884602 ↗
• MalfunctionOct 12, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT OF 30 SECONDS WAS OBTAINED ON ONE PATIENT SAMPLE USING THE DADE ACTIN FSL ACTIVATED PTT REAGENT ON A SYSMEX CA-1500 SYSTEM. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, ONE OF THE SAMPLES FROM THE PATIENT AND A NEW REDRAWN SAMPLE WERE RERUN ON THE SAME SYSTEM AND ON AN ALTERNATE SYSMEX CA-1500 SYSTEM USING THE SAME REAGENTS, FROM THE SAME LOT, RESULTING HIGHER. ONE OF THE REPEAT RESULTS WAS REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE PREVIOUSLY OBTAINED APTT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7962398 ↗
• MalfunctionOct 12, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FLAGGED, ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT WAS OBTAINED ON A PATIENT SAMPLE USING THE DADE ACTIN FSL ACTIVATED PTT REAGENT ON A SYSMEX CA-1500 SYSTEM. THE SAMPLE WAS REPEATED ON AN ALTERNATE SYSMEX CA-1500 SYSTEM USING THE SAME REAGENT LOT, RESULTING IN ANOTHER ELEVATED APTT RESULT. THE SAMPLE WAS REPEATED ON THE INITIAL SYSTEM AND A DISCORDANT, FALSELY LOW RESULT WAS OBTAINED. THE SAMPLE WAS REPEATED TWICE ON THE ALTERNATE SYSTEM, RESULTING IN FLAGGED, ELEVATED APTT RESULTS. THE CUSTOMER REPORTED THE APTT RESULT OF >200 SECONDS, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THE PATIENT WAS REDRAWN AND THE NEW SAMPLE WAS RUN ON ONE OF THE SYSTEMS; A RESULT OF >200 SECONDS WAS OBTAINED ON THE RE-DRAWN SAMPLE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW APTT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7962392 ↗
• MalfunctionJul 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT SHE SUSTAINED A SMALL CUT ON HER HAND FROM BROKEN REAGENT VIALS WHEN OPENING A DADE ACTIN FSL ACTIVATED PTT REAGENT BOX. THE CUSTOMER WASHED THE INJURY WITH WATER AND SOAP AND APPLIED A BANDAGE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BY THE CUSTOMER. THE CUSTOMER INDICATED THAT SHE DISPOSED OF THE BROKEN REAGENT VIALS; UPON INSPECTION OF OTHER REAGENT BOXES, THE CUSTOMER DETERMINED THAT THERE WERE NO OTHER BROKEN REAGENT VIALS. THERE ARE NO KNOWN REPORTS OF MEDICAL INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER'S INJURY TO THE HAND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7709777 ↗
• MalfunctionApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES USING THE DADE ACTIN FSL ACTIVATED PTT REAGENT ON THE SYSMEX CA-1500 SYSTEM. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE RERUN USING FRESH REAGENTS, FROM THE SAME LOT, RESULTING HIGHER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S) FOR TWELVE PATIENTS; THE CUSTOMER INDICATED THAT THE REMAINING PATIENTS DID NOT REQUIRE CORRECTED REPORTS. IT IS UNKNOWN WHETHER THE PATIENTS WERE ON ANTICOAGULATION OR HEPARIN THERAPY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW APTT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7446151 ↗
• MalfunctionApr 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FLAGGED, NON-NUMERICAL ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON FOUR SAMPLES FROM THE SAME PATIENT USING THE DADE ACTIN FSL ACTIVATED PTT REAGENT ON TWO SYSMEX CS-2500 SYSTEMS. THREE SAMPLES WERE RERUN ON THE SAME INSTRUMENTS, RESULTING IN OTHER FLAGGED, NON-NUMERICAL APTT RESULTS. THE CUSTOMER DID NOT PROVIDE THE DATA FOR THE THIRD SAMPLE AND STATED THAT AN APTT RESULT OF APPROXIMATELY 30 SECONDS WAS REPORTED TO THE PHYSICIAN(S). A SAMPLE FROM THIS PATIENT WAS SENT TO ALTERNATE LABORATORY AND RUN USING A SYSMEX CA-7000 SYSTEM, RESULTING IN AN APTT RESULT OF "NO COAGULATION". A CORRECTED REPORT WAS NOT PROVIDED TO THE PHYSICIAN(S). IT WAS ALLEGED THAT THE PATIENT'S HEPARIN ADMINISTRATION WAS DELAYED DUE TO THE DISCORDANT RESULT REPORTED ON THE PATIENT SAMPLE. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT APTT RESULT REPORTED ON THE PATIENT SAMPLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7430140 ↗
• MalfunctionApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NON-NUMERICAL ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS (FLAGGED WITH "NO COAGULATION") WERE OBTAINED ON THREE SAMPLES FROM THE SAME PATIENT USING THE DADE ACTIN FSL ACTIVATED PTT REAGENT ON TWO SYSMEX CS-2500 SYSTEMS. THE LAB PROTOCOL ALLOWS THE OPERATOR TO REPORT RESULTS FLAGGED WITH "NO COAGULATION" AS GREATER THAN THE REPORTING LIMIT AS LONG AS THE OPERATOR REVIEWS THE CURVE AND REFERENCE THE TIME AT 50% AS THE REPORTABLE RESULT. THE FINAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AS <20 SECONDS AND BASED ON THIS RESULT, THE PHYSICIAN(S) RESTARTED THE PATIENT'S HEPARIN DRIP AT 2 AM ON (B)(6) 2018. THE LAB SUPERVISOR WAS MADE AWARE OF THE SITUATION AND NOTIFIED THE PHYSICIAN(S), WHO STOPPED THE PATIENT'S HEPARIN DRIP AT 6 AM ON (B)(6) 2018. ON THE SAME DAY, THE PATIENT'S BLOOD WAS REDRAWN TWICE AND RUN USING THE SAME REAGENT. THE RESULT OBTAINED ON THE SECOND REDRAWN SAMPLE WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FLAGGED APTT RESULT REPORTED ON THE PATIENT SAMPLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7415170 ↗
• MalfunctionMar 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT, FLAGGED WITH "ANALYSIS TIME OVER" AND "EARLY REACTION ERROR", WAS OBTAINED ON A PATIENT SAMPLE USING THE DADE ACTIN FSL ACTIVATED PTT REAGENT ON THE SYSMEX CA-1500 SYSTEM. THE CUSTOMER INDICATED THAT THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). BASED ON THE "SYSMEX CA SERIES MEASUREMENT EVALUATION AND CHECK METHOD SCIENTIFIC BULLETIN" (PAGE 12), THE "ANALYSIS TIME OVER" FLAG DETERMINES WHETHER THE REACTION END POINT IS CORRECT; THIS FLAG IS TRIGGERED WHEN TESTING SAMPLES WITH PROLONGED CLOTTING TIMES. IN SUCH CASES, THE USER SHOULD CHECK THE SAMPLE INTEGRITY, VERIFY THE DELIVERY OF SAMPLE AND REAGENT, SET THE "MAXIMUM READING TIME" TO A LONGER TIME, AND REPEAT ANALYSIS. IF THE REPEAT RESULT IS A NUMERICAL VALUE (WITHOUT AN ASTERISK (*)), THE RESULT CAN BE REPORTED. BASED ON PAGES 18 AND 19 OF THE SAME BULLETIN, THE USER SHOULD NOT REPORT RESULTS WITH "EARLY REACTION ERROR" WITHOUT REVIEWING THE REACTION CURVE. THE USER SHOULD VERIFY SAMPLE AND REAGENT INTEGRITY, PRINT ANALYSIS DATA, CHECK ANALYSIS PRINTOUT, AND REPEAT THE MEASUREMENT. CONSISTENT WITH THE INSTRUCTIONS IN THE BULLETIN, TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7343357 ↗
• MalfunctionFeb 1, 2018High Test Results; High Test Results

  A DISCORDANT HIGH ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) PATIENT RESULT OF 127.4 SECONDS WAS GENERATED ON THE SYSMEX CA-1500 ANALYZER USING DADE ACTIN FSL ACTIVATED PTT REAGENT LOT 547488. THIS RESULT WAS REPORTED TO THE PHYSICIAN WHO DID NOT QUESTION THE RESULT. THE SAME PATIENT SAMPLE WAS TESTED AGAIN ON THE SAME SYSTEM (USING SAME REAGENT LOT 547488) AND AN APTT RESULT OF 56.5 SECONDS WAS GENERATED. THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE WAS TESTED ON THE SAME SYSTEM, BUT A DIFFERENT DADE ACTIN FSL ACTIVATED PTT REAGENT LOT WAS USED AND APTT RESULTS OF 53.2 SECONDS AND 53.3 SECONDS WERE GENERATED. THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE PATIENT WAS REDRAWN AND A NEW SAMPLE WAS TESTED ON THE SAME SYSTEM USING PTT REAGENT LOT 547488. AN APTT RESULT OF 55.9 SECONDS WAS GENERATED. THIS RESULT WAS REPORTED TO THE PHYSICIAN. ALL QUALITY CONTROL (QC) WAS IN RANGE BEFORE TESTING. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH, APTT PATIENT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7233785 ↗
• MalfunctionJan 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CA-1500 SYSTEM. THESE RESULTS WERE NOT PROVIDED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS RESPUN AND RERUN ON THE SAME SYSTEM, RESULTING LOWER. THIS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. ON THE FOLLOWING MORNING, THE PATIENT'S BLOOD WAS REDRAWN AND TESTED FOR APTT AND AN APTT RESULT OF >139 SECONDS WAS OBTAINED ON THE SAMPLE. THE SAMPLE TUBE WAS CHECKED FOR CLOTS, RESPUN AND RERUN ON THE SAME SYSTEM. THE SAME APTT RESULT OF >139 SECONDS WAS OBTAINED ON THE SAMPLE. THIS RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE OPERATOR INDICATED THAT THE RESULT OF > 139 SECONDS WAS NOT DISCORDANT FOR THIS PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED APTT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7180990 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K863594. One submission often covers many models, so check the product and lot details in each record.

• Z-1073-2013 · Mar 11, 2013 · Terminated
  Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
• Z-1043-2012 · Dec 19, 2011 · Terminated
  Dade(R) Actin(R) FSL Activated PTT Reagent Product Usage: Liquid purified soy and rabbit brain phosphatides with plasma activator. An activated partial thromboplastin reagent wit