Dade® Innovin® 10873566Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00630414023472), received between Nov 7, 2017 and Jul 31, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “High 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Low Test Results; Low Test Results

  CUSTOMER REPORTED A FALSELY DEPRESSED PT INR (PROTHROMBIN TIME, INTERNATIONAL NORMALIZED RATIO) RESULT OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH INNOVIN ON THE CA-660 SYSTEM COMPARED TO REFERENCE LAB RESULTS. 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 22672984 ↗
• MalfunctionDec 30, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-660 SYSTEM USING DADE INNOVIN REAGENT. THE SAMPLE WAS REPEATED A SECOND TIME FOR PT AND INR, RECOVERING LOWER. THE SAMPLE WAS REPEATED A THIRD TIME FOR PT AND INR, RECOVERING LOWER THAN BOTH OF THE PREVIOUS TWO RUNS. THE SAMPLE WAS THEN RESPUN AND WAS REPEATED A FOURTH TIME FOR PT AND INR, RECOVERING LOWER THAN THE THREE PREVIOUS RUNS. THE PT AND INR RESULTS FROM THE THIRD RUN 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 FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118266 ↗
• MalfunctionDec 22, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THREE DIFFERENT PROTHROMBIN TIME (PT) RESULTS AND THREE DIFFERENT PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-660 SYSTEM USING DADE INNOVIN REAGENT. NONE OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN WHICH, IF ANY, OF THE RESULTS WERE CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PT AND INR RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13061367 ↗
• MalfunctionOct 15, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-660 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT RESULTS WERE FLAGGED WITH AN "ANALYSIS TIME OVER" ERROR AND WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR PT AND INR, BOTH OF WHICH AGAIN RECOVERED FALSELY ELEVATED. THESE RESULTS WERE NOT FLAGGED AND WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLE WAS THEN REMEASURED FOR PT AND INR, BOTH OF WHICH RECOVERED LOWER. THE LOWER PT AND INR 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, FALSELY ELEVATED PT AND INR RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639468 ↗
• MalfunctionJul 17, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-620 SYSTEM USING DADE INNOVIN REAGENT. PRIOR TO OBTAINING THE DISCORDANT RESULT, THE SAMPLE WAS RUN FOR INR ON THE SAME SYSMEX CA-620 SYSTEM USING DADE INNOVIN REAGENT BUT THE SYSTEM DID NOT YIELD NUMERIC RESULTS AND GENERATED A NO COAGULATION ERROR. AFTER OBTAINING THE INITIAL DISCORDANT RESULT, THE SAMPLE WAS REPEATED FOR INR ON THE SAME SYSTEM WITH THE SAME REAGENT, AND THE REPEAT RESULT RECOVERED AS FALSELY ELEVATED. NEITHER OF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS THEN SENT TO AN ALTERNATE SITE AND WAS RERUN FOR INR USING AN ALTERNATE METHOD. THE INR RECOVERED LOWER. THE PATIENT WAS REDRAWN, AND THE REDRAWN SAMPLE WAS RUN FOR INR ON THE SYSMEX CA-620 SYSTEM USING DADE INNOVIN REAGENT, AND RECOVERED LOWER. BOTH OF THE LOWER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED INR RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10291777 ↗
• MalfunctionJun 23, 2020Low Test Results; Low Test Results

  FOUR DISCORDANT, FALSELY LOW PROTHROMBIN TIME (PT) RESULTS WERE OBTAINED ON FOUR DIFFERENT PATIENT SAMPLES ON A SYSMEX CA-660 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). EACH OF THE FOUR SAMPLES WAS REPEATED TWICE FOR PT ON THE SAME DAY, RECOVERING HIGHER. TWO OF THE FOUR PATIENT WERE REDRAWN THE FOLLOWING DAY AND RUN FOR PT, ALSO RESULTING HIGHER. ALL OF THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PROTHROMBIN TIME (PT) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10184601 ↗
• MalfunctionNov 13, 2019High Test Results; High Test Results

  DISCORDANT, FALSELY HIGH PROTHROMBIN TIME (PT) AND INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON A SYSMEX CA-620 SYSTEM USING THE DADE INNOVIN REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). QUALITY CONTROLS HAD BEEN RUN PRIOR TO PROCESSING OF PATIENT SAMPLES AND RESULTS WERE WITHIN RANGE ACCORDING TO THE TABLE OF ASSIGNED VALUES (TAV). THE PHYSICIAN QUESTIONED THE REPORTED RESULT. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND WAS REPEATED ON THE SAME SYSMEX CA-620 SYSTEM RESULTING LOWER. THIS RESULT WAS CONSIDERED AS CORRECT AND A CORRECTED REPORT WAS SUBMITTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY HIGH PROTHROMBIN TIME AND INTERNATIONAL NORMALIZED RATIO RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9316010 ↗
• MalfunctionAug 28, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT AND A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-620 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED BY THE PHYSICIAN(S). A SECOND SAMPLE FROM THE SAME PATIENT WAS THEN RUN FOR PT AND INR, RESULTING LOWER. THESE RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE FOLLOWING DAY, THE ORIGINAL PATIENT SAMPLE WAS RERUN FOR PT AND INR, ALSO RESULTING LOWER AND CONFIRMING THE RESULTS FROM THE SECOND DRAW FROM THE PREVIOUS DAY. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8941470 ↗
• MalfunctionDec 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHEN THE QUALITY CONTROLS (QCS) RECOVERED OUT OF RANGE ON THE SYSMEX CA-560 SYSTEM, A USER RAN AND OBTAINED A FLAGGED PROTHROMBIN TIME (PT) RESULT OF "NO COAGULATION" ON A PATIENT SAMPLE. THE SAME SAMPLE WAS RERUN ON THE SAME SYSTEM AND THE SYSTEM FLAGGED THE PT RESULT WITH A "NO COAGULATION" ERROR. THE SAME SAMPLE WAS RERUN ON THE SAME SYSTEM AND THE SYSTEM FLAGGED THE RESULT WITH AN "ANALYSIS TIME OVER" ERROR. A NON-NUMERICAL PT RESULT OF "NO COAGULATION" WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. BASED ON REPORTED RESULT, THE PHYSICIAN SENT THE PATIENT TO THE EMERGENCY ROOM (ER), WHERE THE PATIENT'S BLOOD WAS REDRAWN AND RUN ON AN ALTERNATE SYSMEX CA-1500 SYSTEM. AN EXPECTED PT RESULT WAS OBTAINED FOR THIS PATIENT ON THE SYSMEX CA-1500 SYSTEM. WHEN QCS RECOVERED WITHIN RANGE ON THE INITIAL SYSMEX CA-560 SYSTEM, THE USER RERAN BOTH SAMPLES, ORIGINAL AND REDRAWN, AND PT RESULTS, SIMILAR TO THE RESULT OBTAINED ON THE SYSMEX CA-1500 SYSTEM, WERE OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FLAGGED PT RESULTS OBTAINED ON THE PATIENT SAMPLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7121677 ↗
• MalfunctionNov 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FLAGGED PROTHROMBIN TIME (PT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CA-620 SYSTEM. THE CUSTOMER REPORTED THIS RESULT AS >170 SECONDS AND NOTIFIED THE CLINIC THAT THE SAMPLE WILL BE RETESTED AT AN ALTERNATE FACILITY. THE PHYSICIAN DID NOT QUESTION THE RESULT. THE CUSTOMER CHECKED THE SAMPLE INTEGRITY AND CHECKED THE SAMPLE FOR CLOTS. THE CUSTOMER INDICATED THAT THE PATIENT SAMPLE WAS NEITHER LIPEMIC, HEMOLYZED, NOR ICTERIC AND RE-SPUN THE SAMPLE. THE CUSTOMER ALIQUOTED THE SAMPLE INTO TWO SAMPLE CUPS AND SENT A SAMPLE CUP TO AN ALTERNATE FACILITY. AT THE ALTERNATE FACILITY, THE SAMPLE WAS RERUN ON AN ALTERNATE SYSMEX CA-500 SYSTEM AND AN ALTERNATE SYSMEX CA-600 SYSTEM, RESULTING LOWER THAN THE REPORTED RESULT. THE OTHER SAMPLE CUP WAS RERUN ON THE INITIAL SYSMEX CA-620 SYSTEM, RESULTING LOWER THAN THE REPORTED RESULT. A CORRECTED REPORT WITH RESULTS OBTAINED AT THE ALTERNATE FACILITY WAS PROVIDED TO THE PHYSICIAN. THE CORRECTED RESULTS MATCHED THE PATIENT'S CLINICAL HISTORY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PT RESULT REPORTED ON THE PATIENT SAMPLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7006189 ↗