INNOVANCE® D-Dimer 10445982Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00842768022821), received between Sep 13, 2017 and Nov 5, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT D-DIMER RESULTS FOR ONE PATIENT MEASURED NEAT (1:1) AND DILUTED (1:10) WITH THE INNOVANCE D-DIMER REAGENT ON A SYSMEX CS-2500 SYSTEM. THE ERRONEOUS RESULT FROM THE DILUTED SAMPLE WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAME SAMPLE WAS REPEATED NEAT AND DILUTED (1:1, 1:10 AUTOMATIC DILUTION, AND 1:2 MANUAL DILUTION) AND RESULTS WERE STILL DISCORDANT. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT AND WAS REPEATED (NEAT) ON THE SAME INSTRUMENT AND AT ANOTHER LAB ON ANOTHER SYSMEX CS-2500 SYSTEM. THE RESULT FROM THE OTHER LAB WAS CONSIDERED CORRECT AND 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 D-DIMER RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20608708 ↗
• MalfunctionJun 3, 2021Use of Device Problem; Use of Device Problem

  A PATIENT SAMPLE HAD BEEN RUN FOR D-DIMER TWO TIMES ON A SYSMEX CA-660 SYSTEM USING INNOVANCE D-DIMER REAGENT, GENERATING ERROR FLAGS WITHOUT NUMERIC RESULTS. THIS PROMPTED THE CUSTOMER TO PERFORM A MANUAL 1:2 DILUTION OF THE SAMPLE OUTSIDE OF THE SYSMEX CA-660 SYSTEM, BUT INSTEAD OF USING INNOVANCE D-DIMER DILUENT, THE CUSTOMER INCORRECTLY USED OWRENS VERONAL BUFFER (OVB) TO DILUTE THE SAMPLE. THIS RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS NOT QUESTIONED. IT IS UNKNOWN WHAT THE CORRECT D-DIMER RESULT WAS FOR THIS PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE USE OF THE OWRENS VERONAL BUFFER TO DILUTE THE SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11933310 ↗
• MalfunctionFeb 5, 2020Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  THE CUSTOMER REPORTED THAT THEIR INNOVANCE D-DIMER CONTROLS WERE OUT OF RANGE. IT WAS DETERMINED THAT THE CUSTOMER HAD NOT CALIBRATED THE INNOVANCE D-DIMER REAGENT FOR THEIR CURRENT REAGENT KIT LOT NUMBER 48985. BOTH THE REAGENT AND CONTROL LOTS WERE INCORRECT IN THE ANALYZER SETTINGS. THE CUSTOMER COULD NOT PROVIDE THE DATE WHEN THE CURRENT LOTS WERE PUT INTO USE. PATIENT RESULTS WERE REPORTED AFTER THE ASSAY LOT WAS CHANGED AND PRIOR TO THE CONTROLS BEING FOUND TO BE OUT OF RANGE, HOWEVER NONE OF THE RESULTS WERE QUESTIONED OR REPORTED AS DISCORDANT. AFTER THE CONTROLS WERE FOUND TO BE OUT OF RANGE THERE WERE NO PATIENT RESULTS REPORTED. PATIENT SAMPLES WERE RUN ON AN ALTERNATE SYSTEM AT THIS TIME. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INNOVANCE D-DIMER CONTROLS BEING OUT OF RANGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9672841 ↗
• MalfunctionSep 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MULTIPLE POTENTIAL FALSE NEGATIVE D-DIMER RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES USING AN UNACCEPTABLE CALIBRATION CURVE ON THE BCS XP SYSTEM. THE D-DIMER RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE AFFECTED PATIENT SAMPLES WERE NOT RERUN AND CORRECTED REPORTS WERE NOT PROVIDED TO THE PHYSICIAN(S). THE CORRECT RESULTS FOR THE AFFECTED PATIENTS ARE UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIAL FALSE NEGATIVE D-DIMER RESULTS OBTAINED ON THE PATIENT SAMPLES ON THE BCS XP SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861377 ↗
• MalfunctionSep 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MULTIPLE POTENTIAL FALSE NEGATIVE D-DIMER RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES USING AN UNACCEPTABLE CALIBRATION CURVE ON THE BCS XP SYSTEM. THE D-DIMER RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE AFFECTED PATIENT SAMPLES WERE NOT RERUN AND CORRECTED REPORTS WERE NOT PROVIDED TO THE PHYSICIAN(S). THE CORRECT RESULTS FOR THE AFFECTED PATIENTS ARE UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIAL FALSE NEGATIVE D-DIMER RESULTS OBTAINED ON THE PATIENT SAMPLES ON THE BCS XP SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861375 ↗
• MalfunctionSep 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MULTIPLE POTENTIAL FALSE NEGATIVE D-DIMER RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES USING AN UNACCEPTABLE CALIBRATION CURVE ON THE BCS XP SYSTEM. THE D-DIMER RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE AFFECTED PATIENT SAMPLES WERE NOT RERUNED AND CORRECTED REPORTS WERE NOT PROVIDED TO THE PHYSICIAN(S). THE CORRECT RESULTS FOR THE AFFECTED PATIENTS ARE UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIAL FALSE NEGATIVE D-DIMER RESULTS OBTAINED ON THE PATIENT SAMPLES ON THE BCS XP SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861361 ↗
• MalfunctionSep 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MULTIPLE POTENTIAL FALSE NEGATIVE D-DIMER RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES USING AN UNACCEPTABLE CALIBRATION CURVE ON THE BCS XP SYSTEM. THE D-DIMER RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE AFFECTED PATIENT SAMPLES WERE NOT RERUN AND CORRECTED REPORTS WERE NOT PROVIDED TO THE PHYSICIAN(S). THE CORRECT RESULTS FOR THE AFFECTED PATIENTS ARE UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIAL FALSE NEGATIVE D-DIMER RESULTS OBTAINED ON THE PATIENT SAMPLES ON THE BCS XP SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861360 ↗
• MalfunctionSep 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A POTENTIAL FALSE NEGATIVE D-DIMER RESULT WAS OBTAINED ON A PATIENT SAMPLE USING AN UNACCEPTABLE CALIBRATION CURVE ON THE BCS XP SYSTEM. THE D-DIMER RESULT WAS REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULT. THE AFFECTED PATIENT SAMPLE WAS NOT RERUN AND A CORRECTED REPORT WAS NOT PROVIDED TO THE PHYSICIAN. THE CORRECT RESULT FOR THE AFFECTED PATIENT IS UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIAL FALSE NEGATIVE D-DIMER RESULT OBTAINED ON A PATIENT SAMPLE ON THE BCS XP SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861323 ↗