INNOVANCE Heparin 10873535Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842768017438), received between Apr 9, 2018 and Jul 9, 2021 — classified as 5 malfunctions.

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

• MalfunctionJul 9, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  A LAB TECHNICIAN CUT THEIR FINGER ON A BROKEN VIAL OF INNOVANCE HEPARIN REAGENT WHILE OPENING THE OUTER BOX OF THE INNOVANCE HEPARIN REAGENT KIT. THE LAB TECHNICIAN WASHED OUT THE CUT FOR 10 MINUTES WITH WATER. NO MEDICAL INTERVENTION WAS REQUIRED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12143309 ↗
• MalfunctionApr 13, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW HEPARIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-2500 SYSTEM USING INNOVANCE HEPARIN REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED AS THE PATIENT WAS DOSED WITH HEPARIN PRIOR TO OBTAINING THE LOW RESULT. A NEW SAMPLE FROM THE SAME PATIENT WAS REPEATED FOR HEPARIN USING THE SAME SYSTEM AND REAGENT, RECOVERING HIGHER. THIS RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THE INITIAL SAMPLE WAS ALSO REPEATED FOR HEPARIN A SECOND TIME FOR INVESTIGATIONAL USE ONLY AS THE SAMPLE WAS PAST THE STABILITY TIME OF 4 HOURS, STILL RECOVERING FALSELY LOW. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW HEPARIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657696 ↗
• MalfunctionMar 24, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW HEPARIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-2500 SYSTEM USING INNOVANCE HEPARIN REAGENT. THE RESULT WAS FLAGGED WITH A "LOWER REPORT LIMIT OVER" ERROR. THE PATIENT HAD BEEN STARTED ON HEPARIN SIX HOURS BEFORE OBTAINING THE DISCORDANT RESULT. THE HEPARIN DOSAGE WAS STOPPED THE FOLLOWING DAY, AFTER WHICH A SECOND DISCORDANT, FALSELY LOW HEPARIN RESULT WAS OBTAINED. THIS RESULT WAS ALSO FLAGGED WITH A "LOWER REPORT LIMIT OVER" ERROR. THREE HOURS AFTER OBTAINING THIS RESULT, THE PATIENT WAS STARTED ON HEPARIN AGAIN. TWO OTHER SAMPLES FROM THE PATIENT WERE MEASURED FOR HEPARIN LATER THE SAME DAY, RECOVERING HIGHER. THESE HIGHER RESULTS WERE CONSIDERED CORRECT. HEPARIN INFUSION WAS STOPPED FOR THE PATIENT THAT NIGHT. FOR THE FOLLOWING TWO DAYS, EIGHT SAMPLES FROM THE SAME PATIENT WERE MEASURED FOR HEPARIN, ALL RECOVERING ACCEPTABLY IN LINE WITH CHANGES IN HEPARIN DOSAGE OVER THE COURSE OF THE TWO DAYS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW HEPARIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563752 ↗
• MalfunctionMar 24, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW HEPARIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-2500 SYSTEM USING INNOVANCE HEPARIN REAGENT. THE RESULT WAS FLAGGED WITH A "LOWER REPORT LIMIT OVER" ERROR. THE PATIENT HAD BEEN STARTED ON HEPARIN SIX HOURS BEFORE OBTAINING THE DISCORDANT RESULT. THE HEPARIN DOSAGE WAS STOPPED THE FOLLOWING DAY, AFTER WHICH A SECOND DISCORDANT, FALSELY LOW HEPARIN RESULT WAS OBTAINED. THIS RESULT WAS ALSO FLAGGED WITH A "LOWER REPORT LIMIT OVER" ERROR. THREE HOURS AFTER OBTAINING THIS RESULT, THE PATIENT WAS STARTED ON HEPARIN AGAIN. TWO OTHER SAMPLES FROM THE PATIENT WERE MEASURED FOR HEPARIN LATER THE SAME DAY, RECOVERING HIGHER. THESE HIGHER RESULTS WERE CONSIDERED CORRECT. HEPARIN INFUSION WAS STOPPED FOR THE PATIENT THAT NIGHT. FOR THE FOLLOWING TWO DAYS, EIGHT SAMPLES FROM THE SAME PATIENT WERE MEASURED FOR HEPARIN, ALL RECOVERING ACCEPTABLY IN LINE WITH CHANGES IN HEPARIN DOSAGE OVER THE COURSE OF THE TWO DAYS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW HEPARIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563750 ↗
• MalfunctionApr 9, 2018Low Test Results; Low Test Results

  A DISCORDANT, LOW HEPARIN PATIENT RESULT (0.02 IU/ML) USING INNOVANCE HEPARIN KIT LOT 47758 WAS GENERATED ON THE BCS XP ANALYZER. THIS PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE WAS REMIXED AND RECENTRIFUGED ON THE SAME DAY AND RUN ON THE SAME BCS XP ANALYZER. A HIGHER HEPARIN PATIENT RESULT OF 0.44 IU/ML (REPEAT RESULT 1) WAS GENERATED, BUT NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPEATED AGAIN ON THE SAME BCS XP ANALYZER AND A HEPARIN PATIENT RESULT OF 0.45 IU/ML (REPEAT RESULT 2) WAS GENERATED AND REPORTED TO THE PHYSICIAN. THE REPEAT HEPARIN RESULTS MATCHED THE CLINICAL EXPECTATION OF THE PATIENT. QUALITY CONTROL VALUES WERE WITHIN RANGE BEFORE TESTING. THERE WAS NO KNOWN IMPACT OR ADVERSE HEALTH CONSEQUENCE TO THE PATIENT DUE TO THE LOW INNOVANCE HEPARIN RESULT AS THE RESULT WAS NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7409215 ↗