Pathromtin® SL 10446066Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00842768007521), received between Jul 20, 2017 and Oct 15, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K955450); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA COAG 360 SYSTEM USING PATHROMTIN SL REAGENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR APTT, RECOVERING HIGHER. THE HIGHER APTT 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 DISCORDANT, FALSELY LOW APTT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639459 ↗
• MalfunctionJan 11, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON A SYSMEX CS-5100 SYSTEM AND ON A NON-SIEMENS SYSTEM, BOTH USING PATHROMTIN SL REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE ALSO RUN FOR APTT ON A BCS XP SYSTEM USING PATHROMTIN SL REAGENT. THE RESULTS OBTAINED ON THE BCS XP SYSTEMS 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 ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11149111 ↗
• MalfunctionJan 11, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON A SYSMEX CS-5100 SYSTEM AND ON A NON-SIEMENS SYSTEM, BOTH USING PATHROMTIN SL REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE ALSO RUN FOR APTT ON A BCS XP SYSTEM USING PATHROMTIN SL REAGENT. THE RESULTS OBTAINED ON THE BCS XP SYSTEMS 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 ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11149089 ↗
• MalfunctionJan 11, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON A SYSMEX CS-5100 SYSTEM AND ON A NON-SIEMENS SYSTEM, BOTH USING PATHROMTIN SL REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE ALSO RUN FOR APTT ON A BCS XP SYSTEM USING PATHROMTIN SL REAGENT. THE RESULTS OBTAINED ON THE BCS XP SYSTEMS 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 ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11149049 ↗
• MalfunctionOct 26, 2018High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE(S) ON A SYSMEX CS-2500 SYSTEM. THE INITIAL DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. MULTIPLE SAMPLES FROM ONE PATIENT WERE REPEATED ON THE SAME SYSTEM, RESULTING FALSELY HIGH. THE PATIENT WAS RE-DRAWN AND THE NEW SAMPLE WAS RUN ON A NON-SIEMENS INSTRUMENT, RESULTING LOWER. THE RESULT OBTAINED USING THE NON-SIEMENS METHODOLOGY WAS REPORTED, AS THE CORRECT RESULT TO THE PHYSICIAN(S). THE PATIENT'S SCHEDULED ARTHROSCOPIC SURGERY WAS DELAYED DUE TO THE PATHOLOGICAL, FALSELY ELEVATED APTT RESULTS AND FURTHER TESTING WAS REQUIRED. THE PATIENT TESTED NEGATIVE FOR FACTOR AND LUPUS ANTI-COAGULANTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED APTT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8010829 ↗
• MalfunctionOct 26, 2018High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE(S) ON A SYSMEX CS-2500 SYSTEM. THE INITIAL DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. MULTIPLE SAMPLES FROM ONE PATIENT WERE REPEATED ON THE SAME SYSTEM, RESULTING FALSELY HIGH. THE PATIENT WAS RE-DRAWN AND THE NEW SAMPLE WAS RUN ON A NON-SIEMENS INSTRUMENT, RESULTING LOWER. THE RESULT OBTAINED USING THE NON-SIEMENS METHODOLOGY WAS REPORTED, AS THE CORRECT RESULT TO THE PHYSICIAN(S). THE PATIENT'S SCHEDULED ARTHROSCOPIC SURGERY WAS DELAYED DUE TO THE PATHOLOGICAL, FALSELY ELEVATED APTT RESULTS AND FURTHER TESTING WAS REQUIRED. THE PATIENT TESTED NEGATIVE FOR FACTOR AND LUPUS ANTI-COAGULANTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED APTT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8009187 ↗
• MalfunctionOct 26, 2018High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE(S) ON A SYSMEX CS-2500 SYSTEM. THE INITIAL DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. MULTIPLE SAMPLES FROM ONE PATIENT WERE REPEATED ON THE SAME SYSTEM, RESULTING FALSELY HIGH. THE PATIENT WAS RE-DRAWN AND THE NEW SAMPLE WAS RUN ON A NON-SIEMENS INSTRUMENT, RESULTING LOWER. THE RESULT OBTAINED USING THE NON-SIEMENS METHODOLOGY WAS REPORTED, AS THE CORRECT RESULT TO THE PHYSICIAN(S). THE PATIENT'S SCHEDULED ARTHROSCOPIC SURGERY WAS DELAYED DUE TO THE PATHOLOGICAL, FALSELY ELEVATED APTT RESULTS AND FURTHER TESTING WAS REQUIRED. THE PATIENT TESTED NEGATIVE FOR FACTOR AND LUPUS ANTI-COAGULANTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED APTT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8009184 ↗
• MalfunctionOct 26, 2018High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE(S) ON A SYSMEX CS-2500 SYSTEM. THE INITIAL DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. MULTIPLE SAMPLES FROM ONE PATIENT WERE REPEATED ON THE SAME SYSTEM, RESULTING FALSELY HIGH. THE PATIENT WAS RE-DRAWN AND THE NEW SAMPLE WAS RUN ON A NON-SIEMENS INSTRUMENT, RESULTING LOWER. THE RESULT OBTAINED USING THE NON-SIEMENS METHODOLOGY WAS REPORTED, AS THE CORRECT RESULT TO THE PHYSICIAN(S). THE PATIENT'S SCHEDULED ARTHROSCOPIC SURGERY WAS DELAYED DUE TO THE PATHOLOGICAL, FALSELY ELEVATED APTT RESULTS AND FURTHER TESTING WAS REQUIRED. THE PATIENT TESTED NEGATIVE FOR FACTOR AND LUPUS ANTI-COAGULANTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED APTT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8009180 ↗
• MalfunctionJul 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS ADMINISTERED LOW-MOLECULAR WEIGHT (LMW) HEPARIN THERAPY AFTER RECEIVING SURGERY AND TESTED FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT). IN PARALLEL, THE OPERATOR ANALYZED THE PATIENT BLOOD FOR APTT USING THE ACTIN FSL AND PATHROMTIN SL REAGENTS AND OBTAINED DIFFERENT APTT RESULTS. THE OPERATOR OBTAINED AN APTT RESULT OF 152 SECONDS USING THE PATHROMTIN SL REAGENT AND OBTAINED AN APTT RESULT OF 30 SECONDS USING THE ACTIN FSL REAGENT. IT IS UNKNOWN IF ANY RESULTS WERE REPORTED TO THE PHYSICIAN. THE OPERATOR INDICATED THEY EXPLAINED THE SITUATION TO THE PHYSICIAN SUCH THAT THESE APTT RESULTS DID NOT AFFECT THE PATIENT. THE OPERATOR INDICATED THAT THE PHYSICIAN TREATED THE PATIENT ACCORDING TO STANDARD MEDICAL PROTOCOLS AND OTHER TEST RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT APTT RESULTS OBTAINED BETWEEN THE PATHROMTIN SL AND ACTIN FSL REAGENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6730214 ↗
• MalfunctionJul 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS ADMINISTERED LOW-MOLECULAR WEIGHT (LMW) HEPARIN THERAPY AFTER RECEIVING SURGERY AND TESTED FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT). IN PARALLEL, THE OPERATOR ANALYZED THE PATIENT BLOOD FOR APTT USING THE ACTIN FSL AND PATHROMTIN SL REAGENTS AND OBTAINED DIFFERENT APTT RESULTS. THE OPERATOR OBTAINED AN APTT RESULT OF 169.5 SECONDS USING THE PATHROMTIN SL REAGENT AND OBTAINED AN APTT RESULT OF 28 SECONDS USING THE ACTIN FSL REAGENT. AN APTT RESULT OF 169.5 SECONDS WAS REPORTED TO THE PHYSICIAN. THE OPERATOR STATED THAT APTT RESULT OBTAINED USING THE PATHROMTIN SL REAGENT WAS CONSIDERED DISCORDANT SINCE APTT RESULTS GENERALLY WILL NOT INCREASE DUE TO LMW HEPARIN THERAPY. THE OPERATOR INDICATED THEY EXPLAINED THE SITUATION TO THE PHYSICIAN SUCH THAT THESE APTT RESULTS DID NOT AFFECT THE PATIENT. THE OPERATOR INDICATED THAT THE PHYSICIAN TREATED THE PATIENT ACCORDING TO STANDARD MEDICAL PROTOCOLS AND OTHER TEST RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT APTT RESULTS OBTAINED BETWEEN THE PATHROMTIN SL AND ACTIN FSL REAGENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6730153 ↗
• MalfunctionJul 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS ADMINISTERED LOW-MOLECULAR WEIGHT (LMW) HEPARIN THERAPY AFTER RECEIVING SURGERY AND TESTED FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT). IN PARALLEL, THE OPERATOR ANALYZED THE PATIENT BLOOD FOR APTT USING THE ACTIN FSL AND PATHROMTIN SL REAGENTS AND OBTAINED DIFFERENT APTT RESULTS. THE OPERATOR OBTAINED AN APTT RESULT OF 127.8 SECONDS USING THE PATHROMTIN SL REAGENT AND OBTAINED AN APTT RESULT OF 29 SECONDS USING THE ACTIN FSL REAGENT. IT IS UNKNOWN IF ANY RESULTS WERE REPORTED TO THE PHYSICIAN. THE OPERATOR INDICATED THEY EXPLAINED THE SITUATION TO THE PHYSICIAN SUCH THAT THESE APTT RESULTS DID NOT AFFECT THE PATIENT. THE OPERATOR INDICATED THAT THE PHYSICIAN TREATED THE PATIENT ACCORDING TO STANDARD MEDICAL PROTOCOLS AND OTHER TEST RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT APTT RESULTS OBTAINED BETWEEN THE PATHROMTIN SL AND ACTIN FSL REAGENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6730078 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K955450. One submission often covers many models, so check the product and lot details in each record.

• Z-0773-04 · Mar 1, 2004 · Terminated
  Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials