HemosIL HIT-Ab(PF4-H) 00020014600Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08426950975380), received between Apr 22, 2024 and Aug 7, 2025 — classified as 1 death, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (4 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, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  POTENTIALLY ERRONEOUS RESULT GENERATED DUE TO HIT ALTERNATIVE PREDILUTION (D) TEST BEING ORDERED INSTEAD OF THE MAIN TEST USING HEMOSIL HIT-AB (PF4-H) LOT B37012 ON ACL TOP 550 CTS SN (B)(6). A COMPLAINT WAS SUBMITTED ON HEMOSIL HIT-AB (PF4-H), LOT B37012, PN 00020014600, INDICATING THAT A LABORATORY USER MISTAKENLY ORDERED AND PERFORMED A HIT ALTERNATIVE PREDILUTION (D) TEST INSTEAD OF THE STANDARD HIT_AB TEST ON (B)(6) 2025. AT THIS TIME, THE IMPACT ON THE PATIENT REMAINS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22737450 ↗
• MalfunctionJun 18, 2025False Negative Result; Adverse Event Without Identified Device or Use Problem; False Negative Result; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS FILED ON MAY 20, 2025 REGARDING A DISCREPANT HIT TEST RESULT. THE PATIENT'S HIT RESULTS ON THE ACL TOP INSTRUMENT RETURNED A NEGATIVE RESULT, BUT A FOLLOW-UP SRA CONDUCTED AT AN EXTERNAL FACILITY ON YIELDED A POSITIVE RESULT. THE INSTRUMENT WAS CALIBRATED ON (B)(6) 2025. DUE TO CLINICAL SUSPICION, THE PATIENT WAS INITIALLY TREATED WITH AN ALTERNATIVE ANTICOAGULANT, BRIEFLY SWITCHED BACK TO HEPARIN, AND THEN RESUMED APPROPRIATE THERAPY (BIVALIRUDIN AND LATER APIXABAN) UPON RECEIVING THE POSITIVE SRA. THE ORIGINAL SERUM SAMPLE HAS BEEN DISCARDED, AND NO ELISA TESTING WAS PERFORMED. NO KNOWN PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22284252 ↗
• DeathMay 28, 2025False Negative Result; False Negative Result

  A COMPLAINT HAS BEEN FILED FOR A DISCREPANT HIT TEST RESULT. THE PATIENT SAMPLE ID (B)(6), TESTED ON THE ACL TOP USING REAGENT/CALIBRATOR PN 00020014600, YIELDED A NEGATIVE RESULT. THE SAME SAMPLE, WHEN SENT TO MAYO CLINIC, RETURNED A POSITIVE SRA RESULT (CUT-OFF: >0.400 POSITIVE). THE SAMPLE WAS INITIALLY SENT TO MAYO AFTER PHARMACY QUESTIONED THE NEGATIVE RESULT, GIVEN THE PATIENT'S CLINICAL HISTORY OF A LEFT APICAL THROMBUS, STROKE, AND SUBSEQUENT DEATH UNDER PALLIATIVE CARE. THE SITE HAS NOW DISCONTINUED HIT TESTING ON THE ACL TOP AND IS SENDING SAMPLES TO QUEST.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 22100252 ↗
• InjuryApr 24, 2024False Negative Result; False Negative Result

  CUSTOMER REPORTED TWO COMPLAINTS REGARDING A NEGATIVE RESULT FOR HIT-AB RUN ON TWO SEPARATE ACL TOP 700 INSTRUMENTS. A SEPARATE REPORT (1217183-2024-00002) HAS BEEN FILED FOR THE SAMPLE ANALYZED ON ACL TOP 700 SERIAL NUMBER (B)(6). IT WAS REPORTED THAT A PATIENT SUSPECTED OF HIT RECEIVED A NEGATIVE RESULT ON THE ACL TOP 700 SERIAL NUMBER (B)(6). OTHER METHODS OF TESTING (ELISA AND SRA) WERE POSITIVE. THE CUSTOMER CONSIDERS THE NEGATIVE RESULT FROM THE ACL TOP 700 ERRONEOUS. THE NEGATIVE RESULT FROM THE ACL TOP 700 WAS NOT REPORTED, AS THE POSITIVE ELISA TEST FIT THE PATIENT'S PROFILE. NO CORRECTED REPORT WAS ISSUED AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175720 ↗
• InjuryApr 22, 2024False Negative Result; False Negative Result

  CUSTOMER REPORTED TWO COMPLAINTS REGARDING A NEGATIVE RESULT FOR HIT-AB RUN ON TWO SEPARATE ACL TOP 700 INSTRUMENTS. A SEPARATE REPORT (1217183-2024-00003) HAS BEEN FILED FOR THE SAMPLE ANALYZED ON ACL TOP 700 SERIAL NUMBER (B)(6). IT WAS REPORTED THAT A PATIENT SUSPECTED OF HIT RECEIVED A NEGATIVE RESULT ON THE ACL TOP 700 SERIAL NUMBER (B)(6). OTHER METHODS OF TESTING (ELISA AND SRA) WERE POSITIVE. THE CUSTOMER CONSIDERS THE NEGATIVE RESULT FROM THE ACL TOP 700 ERRONEOUS. THE NEGATIVE RESULT FROM THE ACL TOP 700 WAS NOT REPORTED, AS THE POSITIVE ELISA TEST FIT THE PATIENT'S PROFILE. NO CORRECTED REPORT WAS ISSUED AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160534 ↗