INNOVANCE VWF Ac 10487040Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842768028014), received between Oct 22, 2024 and May 21, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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 16, 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.

• MalfunctionMay 21, 2026Low Test Results

  THE CUSTOMER REPORTED A FALSELY DEPRESSED INNOVANCE VWF AC RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BCS XP INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT THE REPEAT RESULT WAS HIGHER 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 DISCORDANT, FALSELY DEPRESSED INNOVANCE VWF AC RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241346 ↗
• MalfunctionMay 21, 2026Low Test Results

  THE CUSTOMER REPORTED A FALSELY DEPRESSED INNOVANCE VWF AC RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BCS XP INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT WAS HIGHER 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 DISCORDANT, FALSELY DEPRESSED INNOVANCE VWF AC RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241321 ↗
• MalfunctionApr 24, 2026Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED INNOVANCE VWF AC (VON-WILLEBRAND FACTOR ACTIVITY) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON CS-5100 INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE HIGHER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, DEPRESSED VWF-AC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980030 ↗
• MalfunctionOct 22, 2024High Test Results; High Test Results

  A CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED VON WILLEBRAND FACTOR ACTIVITY (VWF AC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM USING INNOVANCE VWF AC REAGENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). TWO DAYS LATER, THE SAMPLE WAS REPEATED THREE TIMES FOR VWF AC USING THE SAME REAGENT ON AN ALTERNATE BCS XP SYSTEM. TWO OF THE THREE RESULTS RECOVERED FALSELY ELEVATED AND THE FIRST RESULT RECOVERED LOWER. THE LOWER RESULT WAS CONSIDERED TO BE THE CORRECT RESULT FOR THE PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED VWF AC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20508117 ↗
• MalfunctionOct 22, 2024High Test Results; High Test Results

  A CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED VON WILLEBRAND FACTOR ACTIVITY (VWF AC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM USING INNOVANCE VWF AC REAGENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). TWO DAYS LATER, THE SAMPLE WAS REPEATED THREE TIMES FOR VWF AC USING THE SAME REAGENT ON AN ALTERNATE BCS XP SYSTEM. TWO OF THE THREE RESULTS RECOVERED FALSELY ELEVATED AND THE FIRST RESULT RECOVERED LOWER. THE LOWER RESULT WAS CONSIDERED TO BE THE CORRECT RESULT FOR THE PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED VWF AC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20508112 ↗