Pathromtin® SL 10446067Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842768007538), received between Sep 29, 2017 and Sep 6, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2023High Test Results; High Test Results

  FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON A PATIENT SAMPLE USING PATHROMTIN SL REAGENT ON TWO SYSMEX CS-5100 SYSTEMS. THE FIRST ERRONEOUS RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN(S) AS THE PATIENT PREVIOUSLY HAD A LOWER APTT RESULT TWO DAYS PRIOR. THE SAMPLE WAS THEN REPEATED FOR APTT ON A NON-SIEMENS ANALYZER USING A NON-SIEMENS REAGENT, RECOVERING LOWER. THE LOWER 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 APTT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695213 ↗
• MalfunctionSep 6, 2023Low Test Results; Low Test Results

  THREE FALSELY DEPRESSED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED USING PATHROMTIN SL REAGENT ON A PATIENT SAMPLE ON TWO SYSMEX CS-5100 SYSTEMS. WHEN THE SAMPLE WAS INITIALLY PROCESSED ON ONE OF THE SYSMEX CS-5100 SYSTEMS, THE INITIAL APTT RESULT OBTAINED ON SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(6)) RECOVERED HIGHER. THE INITIAL 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 FALSELY LOW APTT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695203 ↗
• MalfunctionSep 29, 2017High Test Results; High Test Results

  A DISCORDANT, HIGH ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT OF 115 SECONDS ON ONE PATIENT SAMPLE WAS GENERATED ON THE SYSMEX CS-5100 ANALYZER USING THE PATHROMTIN SL ASSAY (LOT 536693). THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE, USING A DIFFERENT LOT OF PATHROMTIN SL REAGENT (LOT 536695), WAS TESTED ON A BCS XP SYSTEM GENERATING AN APTT RESULT OF 35.5 SECONDS. THIS RESULT WAS IN LINE WITH THE CLINICAL PICTURE OF THE PATIENT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE HIGH APTT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6904643 ↗

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