Dade InnovinRecalls & reported problems across all models
Siemens Healthcare Diagnostics Products GmbH · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 109
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 5 models of Dade Innovin by Siemens Healthcare Diagnostics Products GmbH in the FDA's device registry (GUDID). Together they are named in 109 adverse event reports in the FDA's MAUDE database, received between Jun 30, 2017 and Mar 20, 2026 — classified as 109 malfunctions.
The most frequently reported specific device problem is “High Test Results” (52 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Dade Innovin problems
Device problems
- High Test Results52
- Adverse Event Without Identified Device or Use Problem25
- Incorrect, Inadequate or Imprecise Result or Readings19
- Low Test Results9
- Incorrect Or Inadequate Test Results6
- Mechanical Problem2
- False Positive Result1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Known Impact Or Consequence To Patient79
- No Clinical Signs, Symptoms or Conditions29
- Laceration(s)1
Dade Innovin models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Dade® Innovin® 10445706TEST, TIME, PROTHROMBIN35 reports
- Dade® Innovin® 10445704TEST, TIME, PROTHROMBIN32 reports
- Dade® Innovin® 10873567TEST, TIME, PROTHROMBIN30 reports
- Dade® Innovin® 10873566TEST, TIME, PROTHROMBIN10 reports
- Dade® Innovin® 10445705TEST, TIME, PROTHROMBIN2 reports
Recent Dade Innovin adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026False Positive Result
THE CUSTOMER REPORTED FALSELY ELEVATED PT (PROTHROMBIN TIME) INR (INTERNATIONAL NORMALIZED RATIO) AND SEC (SECONDS) RESULTS OBTAINED ON A PATIENT SAMPLE MEASURED WITH DADE INNOVIN ON THE CA-660 INSTRUMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULT. 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 THIS DISCORDANT FALSELY ELEVATED PT INR AND SEC RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646948 ↗MalfunctionDec 30, 2025High Test Results; High Test Results
THE CUSTOMER REPORTED THE OBSERVATION THAT THE INR AND THE ASSOCIATED PT.SEC DETERMINATIONS OF A PATIENT SAMPLE PERFORMED WITH DADE INNOVIN ON CS-2500 S/N (B)(6) WERE FALSELY ELEVATED COMPARED TO REPEAT TESTING ON CS-5100 S/N (B)(6) AND THE CLINICAL PICTURE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23920619 ↗MalfunctionSep 3, 2025High Test Results; High Test Results
THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT INCREASED PT (PROTHROMBIN TIME) INR (INTERNATIONAL NORMALIZED RATIO) RESULTS OBTAINED ON FIVE PATIENT SAMPLES MEASURED WITH DADE INNOVIN ON THE CN-3000 INSTRUMENT COMPARED TO REPEAT TESTING. IT IS UNKNOWN WHETHER PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN. PATIENT SAMPLE TESTING WAS REPEATED AS QUALITY CONTROL RESULTS WERE OUT OF RANGE AND INVALIDATED THE INITIAL RUN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS DISCORDANT RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22949724 ↗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 ↗MalfunctionJun 10, 2025High Test Results; High Test Results
THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT INCREASED INR RESULTS AND FALSELY ELEVATED PT (PROTHROMBIN TIME) SEC RESULTS OBTAINED ON A PATIENT SAMPLE MEASURED WITH DADE INNOVIN ON THE CS-2500 INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22175775 ↗MalfunctionMay 26, 2025High Test Results; High Test Results
THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT INCREASED INR RESULTS AND FALSELY ELEVATED PT (PROTHROMBIN TIME) SEC RESULTS OBTAINED ON PATIENT SAMPLE MEASURED WITH DADE INNOVIN ON THE CS-5100 INSTRUMENT COMPARED TO THE ALTERNATE METHOD. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS DISCORDANT RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22083269 ↗MalfunctionDec 2, 2024Use of Device Problem; High Test Results; Use of Device Problem; High Test Results
THE CUSTOMER OBTAINED NON-NUMERIC, FLAGGED, INR PATIENT RESULTS AND FALSELY ELEVATED PT RESULTS MEASURED WITH DADE INNOVIN REAGENT ON A SYSMEX CS-2500 INSTRUMENT. THE CUSTOMER MANUALLY CALCULATED AN INR RESULT OF 10.0 SECONDS AND THIS RESULT WAS REPORTED TO, AND QUESTIONED BY, THE PHYSICIAN(S). THE SAMPLE WAS REPEATED AT ANOTHER LABORATORY AND AN INR RESULT OF 2.3 SECONDS WAS OBTAINED AND REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). A SECOND SAMPLE FROM THE PATIENT WAS ALSO TESTED ON THE INITIAL INSTRUMENT AND RESULTS OF PT 22.1 SECONDS, INR 2.02 SECONDS WERE OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20818238 ↗MalfunctionJul 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED DISCORDANT PROTHROMBIN TIME (PT) RESULTS MEASURED WITH THE BFT II ANALYZER COMPARED TO THE CA-500 SYSTEM AND ABOUT DISCREPANCIES OF RESULTS WITHIN RUN ON BFT II ANALYZER WHEN SAMPLE WAS MEASURED IN TWO-FOLD DETERMINATION. ONLY ONE SPECIFIC PATIENT (DESCRIBED AS PATIENT X) IS AFFECTED. ERRONEOUS RESULTS WERE NOT PROVIDED TO THE PHYSICIAN(S). THE REPEAT RESULTS ON THE CA-500 SYSTEM 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 PROTHROMBIN TIME RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19648653 ↗MalfunctionMar 3, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
SYSMEX REPORTED TO SIEMENS THAT A CUSTOMER SUSTAINED AN INJURY TO THE HAND WHILE OPENING A DADE INNOVIN VIAL, WHICH WAS DIRECTLY EXTRACTED FROM THE PACKAGING BOX. THE CUSTOMER DEMONSTRATED THE NECK OF THE VIAL WAS BROKEN. THE CUSTOMER WAS THEN GIVEN A MINI X-RAY TO ENSURE THAT THERE WERE NO GLASS FRAGMENTS IN THE WOUND. THE WOUND WAS CLEANED AND DISINFECTED AND PROTECTED WITH STERI-STRIPS. NO FURTHER TREATMENT WAS NECESSARY. THE CUSTOMER RETURNED TO WORK THE SAME DAY. THE CUSTOMER WAS WEARING A LAB COAT AND LATEX GLOVES AT THE TIME OF THE INCIDENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: Laceration(s)
MAUDE report 16482208 ↗MalfunctionDec 2, 2022High Test Results; High Test Results
THREE FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULTS AND THREE FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-620 SYSTEM USING DADE INNOVIN REAGENT. A HIGH INR RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE PATIENT WAS REDRAWN AND WAS RERUN FOR PT AND INR, RECOVERING LOWER. THE LOWER RESULTS WERE IN LINE WITH THE PATIENT'S HOME METER. THE LOWER INR 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 FALSELY ELEVATED PT AND INR RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15904526 ↗MalfunctionJun 3, 2022High 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 REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS THEN REPEATED TWO TIMES FOR PT AND INR, RECOVERING LOWER. THE LOWER 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 LOW PT AND INR RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14595326 ↗MalfunctionFeb 17, 2022High Test Results; High Test Results
A NON-NUMERIC PROTHROMBIN TIME (PT) RESULT FLAGGED WITH A "NO COAGULATION" ERROR FLAG WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-660 SYSTEM USING DADE INNOVIN REAGENT. THE SAMPLE WAS REPEATED FOR PT ON THE SAME SYSTEM WITH THE SAME REAGENT, AGAIN GIVING A NON-NUMERIC RESULT FLAGGED WITH A "NO COAGULATION" ERROR FLAG. THE SAMPLE WAS THEN REPEATED FOR PT ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING FALSELY ELEVATED. THE SAMPLE WAS THEN REPEATED FOR PT ON THE SAME SYSTEM WITH THE SAME REAGENT, GIVING A NON-NUMERIC RESULT FLAGGED WITH A "NO COAGULATION" ERROR FLAG. THE SAMPLE WAS THEN REPEATED FOR PT ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING LOWER. THE SAMPLE WAS THEN REPEATED FOR PT ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING LOWER. THE SAMPLE WAS THEN SENT TO AN ALTERNATE HOSPITAL TO BE RUN FOR PT AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR). THE PT RESULT RECOVERED LOWER. THE PT AND INR RESULTS OBTAINED AT THE ALTERNATE HOSPITAL 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 PT RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13552450 ↗MalfunctionJan 6, 2022Low Test Results; Low Test Results
A DISCORDANT, FALSELY LOW PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-660 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT SUBSEQUENTLY HAD A BLEEDING EPISODE AND WAS GIVEN VITAMIN K AND PROTHROMBINEX. THERE WAS A DELAY IN ADMINISTERING VITAMIN K AND PROTHROMBINEX DUE TO THE LOW RESULT. THE FOLLOWING DAY, THE SAME SAMPLE WAS RERUN FOR INR, RECOVERING HIGHER. THE PATIENT WAS THEN REDRAWN AND THE REDRAWN SAMPLE WAS RUN TWICE FOR INR, RECOVERING HIGHER THAN THE INITIAL DISCORDANT RESULT. THE HIGHER INR RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT, THE DELAY IN ADMINISTERING VITAMIN K AND PROTHROMBINEX, OR DUE TO THE BLEEDING. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVEN'T BEEN VERIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13178845 ↗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 ↗
Other Siemens Healthcare Diagnostics Products GmbH products
All Siemens Healthcare Diagnostics Products GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page