INNOVANCE® D-Dimer 10445981Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00842768022814), received between Nov 5, 2018 and Jun 30, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THE OBSERVATION OF A DISCORDANT NEGATIVE D-DIMER PATIENT SAMPLE RESULT OBTAINED ON PATIENT SAMPLE MEASURED WITH INNOVANCE D-DIMER ON CA-660 INSTRUMENT COMPARED TO REPEAT TESTING. THE DISCORDANT NEGATIVE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355954 ↗
• MalfunctionMar 1, 2023Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED THAT A PHYSICIAN MISINTERPRETED AN INNOVANCE D-DIMER RESULT OF 0.93 MCG/ML WITH A REFERENCE RANGE OF 0.19 TO 1.12 MCG/ML FROM THE SYSMEX CS-2500 SYSTEM AS A RESULT WITHIN THE NORMAL RANGE, INSTEAD OF ABOVE THE CUT-OFF FOR THE EXCLUSION OF VENOUS THROMBOEMBOLISM (VTE). AS A RESULT, THE PHYSICIAN(S) SENT THE PATIENT HOME WITHOUT FURTHER TESTING. AFTER REALIZING THE MISINTERPRETATION, THE PHYSICIAN(S) RE-EVALUATED THE CASE AND DETERMINED THAT THE PATIENT WAS NOT AT RISK OF VTE. THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16460696 ↗
• MalfunctionAug 13, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A D-DIMER RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-660 SYSTEM USING INNOVANCE D-DIMER REAGENT. THE CUSTOMER RERAN THE SAMPLE FOR D-DIMER USING THE D-DIMER+ (DDI+) APPLICATION WITH THE SAME SYSTEM AND REAGENT, RECOVERING LOWER. A SECOND SAMPLE FROM THE SAME PATIENT WAS RUN FOR D-DIMER USING THE SAME SYSTEM AND REAGENT, RECOVERING HIGHER. THE REDRAWN SAMPLE WAS REPEATED AGAIN FOR D-DIMER USING THE DDI+ APPLICATION WITH THE SAME SYSTEM AND REAGENT, RECOVERING LOWER. THE HIGHER D-DIMER RESULT WAS REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN WHICH D-DIMER RESULT WAS CONSIDERED CORRECT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT D-DIMER RESULT(S).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10404576 ↗
• MalfunctionJul 20, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A DISCORDANT D-DIMER RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-660 SYSTEM USING INNOVANCE D-DIMER REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). PRIOR TO OBTAINING THE DISCORDANT RESULT, THE SAMPLE WAS RUN FOR D-DIMER TWICE ON THE SYSMEX CA-660 SYSTEM USING INNOVANCE D-DIMER REAGENT, BUT THE SYSTEM DID NOT YIELD NUMERIC RESULTS AND GENERATED MEASUREMENT ERROR FLAGS. THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED FOR D-DIMER ON THE SAME SYSMEX CA-660 SYSTEM USING INNOVANCE D-DIMER REAGENT, RESULTING LOWER. THIS RESULT WAS ALSO CONSIDERED DISCORDANT AND WAS NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT D-DIMER RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10295865 ↗
• MalfunctionJul 20, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A DISCORDANT D-DIMER RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-660 SYSTEM USING INNOVANCE D-DIMER REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). PRIOR TO OBTAINING THE DISCORDANT RESULT, THE SAMPLE WAS RUN FOR D-DIMER TWICE ON THE SYSMEX CA-660 SYSTEM USING INNOVANCE D-DIMER REAGENT, BUT THE SYSTEM DID NOT YIELD NUMERIC RESULTS AND GENERATED MEASUREMENT ERROR FLAGS. THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED FOR D-DIMER ON THE SAME SYSMEX CA-660 SYSTEM USING INNOVANCE D-DIMER REAGENT, RESULTING LOWER. THIS RESULT WAS ALSO CONSIDERED DISCORDANT AND WAS NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT D-DIMER RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10295862 ↗
• MalfunctionMay 6, 2020Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW D-DIMER RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON TWO DIFFERENT SYSMEX CA-1500 SYSTEMS USING INNOVANCE D-DIMER REAGENT. WHEN THE PATIENT SAMPLE WAS INITIALLY RUN FOR D-DIMER ON A SYSMEX CA-1500 SYSTEM USING INNOVANCE D-DIMER REAGENT, THE SYSTEM GENERATED A "RANGE OVER" ERROR CODE AND DID NOT GIVE A RESULT. THE SAMPLE WAS REPEATED FOR D-DIMER ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING ABOVE THE LAB'S D-DIMER CUTOFF. THIS RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS THEN REPEATED FOR D-DIMER ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING BELOW THE CUTOFF. THIS RESULT WAS CONSIDERED DISCORDANT AND WAS NOT REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED FOR D-DIMER ON AN ALTERNATE SYSMEX CA-1500 SYSTEM USING D-DIMER REAGENT, WHICH ALSO RECOVERED BELOW THE CUTOFF. THIS RESULT WAS ALSO CONSIDERED DISCORDANT AND WAS NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW D-DIMER RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10028727 ↗
• MalfunctionMay 6, 2020Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW D-DIMER RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON TWO DIFFERENT SYSMEX CA-1500 SYSTEMS USING INNOVANCE D-DIMER REAGENT. WHEN THE PATIENT SAMPLE WAS INITIALLY RUN FOR D-DIMER ON A SYSMEX CA-1500 SYSTEM USING INNOVANCE D-DIMER REAGENT, THE SYSTEM GENERATED A "RANGE OVER" ERROR CODE AND DID NOT GIVE A RESULT. THE SAMPLE WAS REPEATED FOR D-DIMER ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING ABOVE THE LAB'S D-DIMER CUTOFF. THIS RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS THEN REPEATED FOR D-DIMER ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING BELOW THE CUTOFF. THIS RESULT WAS CONSIDERED DISCORDANT AND WAS NOT REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED FOR D-DIMER ON AN ALTERNATE SYSMEX CA-1500 SYSTEM USING D-DIMER REAGENT, WHICH ALSO RECOVERED BELOW THE CUTOFF. THIS RESULT WAS ALSO CONSIDERED DISCORDANT AND WAS NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW D-DIMER RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10028723 ↗
• MalfunctionMay 29, 2019Off-Label Use; Off-Label Use

  A DISCORDANT, FALSELY LOW D-DIMER RESULT WAS OBTAINED ON A (B)(6) FEMALE PATIENT USING INNOVANCE D-DIMER KIT LOT 48736 ON A SYSMEX CA-660 (SERIAL NUMBER: (B)(4)) SYSTEM. THE PATIENT UNDERWENT A SURGERY ABOUT A WEEK PRIOR TO THE DATE OF THE OBTAINED DISCORDANT RESULT AND THE REASON IS UNKNOWN. THE DISCORDANT RESULT WAS OBTAINED USING A BECTON-DICKINSON (BD) 1.8 ML COAGULATION TUBE; THE SAMPLE WAS REPEATED TWICE WITH EACH REPEAT BEING FLAGGED BY THE INSTRUMENT AND NON-NUMERICAL VALUE OBTAINED. THE INITIAL, NON-FLAGGED, RESULT WAS REPORTED TO THE PHYSICIAN(S) AND IT WAS QUESTIONED. THE PATIENT WAS REDRAWN IN A BD 2.7 ML COAGULATION TUBE FOR ADDITIONAL REPEAT TESTING AND THE RESULTS OBTAINED WERE HIGHER, WHICH MATCHED THE PATIENT CLINICAL HISTORY. A CORRECTED REPORTED WAS ISSUED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW D-DIMER RESULT OBTAINED ON THE SYSMEX CA-660 SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8651273 ↗
• MalfunctionNov 5, 2018Off-Label Use; Low Test Results; Off-Label Use; Low Test Results

  A DISCORDANT, FALSELY LOW D-DIMER RESULT WAS OBTAINED ON A PATIENT SAMPLE WHEN THE SAMPLE WAS DILUTED AND REPEATED ON A SYSMEX CA-1500 SYSTEM, USING THE INNOVANCE D-DIMER REAGENT. WHEN THE SAMPLE WAS INITIALLY RUN, A HIGHER D-DIMER RESULT WAS OBTAINED ON THE PATIENT SAMPLE. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND RECALLED BEFORE THE PHYSICIAN(S) SAW THE RESULT. THE SAMPLE WAS REPEATED MULTIPLE TIMES ON THE SAME SYSTEM UNDER DIFFERENT SAMPLE IDS, RESULTING HIGHER. THE REPEAT RESULT OF 4.09 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 D-DIMER RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8039059 ↗