Dade® Innovin® 10445705Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842768003790), received between Feb 1, 2018 and Jul 1, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionFeb 1, 2018High Test Results; High Test Results

  A DISCORDANT HIGH PROTHROMBIN TIME (PT)/INTERNATIONAL NORMALIZED RATIO (INR) PATIENT RESULT (PT EXTENDED >160 SECONDS / INR >16.0) WAS GENERATED ON A SYSMEX CA-620 ANALYZER AND REPORTED TO THE PHYSICIAN. THE PHYSICIAN DID NOT QUESTION THE RESULT. PT QUALITY CONTROL (QC) WAS WITHIN RANGE AT THE TIME OF TESTING. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT AND A REDRAW SAMPLE WAS TESTED ON A SYSMEX CA-1500 ANALYZER AT THE HOSPITAL LAB. THIS PT/INR PATIENT RESULT (PT 20.7/ INR 2.0) WAS WITHIN THE THERAPEUTIC RANGE FOR ANTICOAGULANT THERAPY AND REPORTED TO THE PHYSICIAN. THE PATIENT DID NOT RECEIVE ANY ADDITIONAL TREATMENT AND WAS DISCHARGED. THE CUSTOMER REPEATED THE ORIGINAL PATIENT SAMPLE THE NEXT DAY (AFTER REMIX/RE-CENTRIFUGATION) ON THE SAME SYSMEX CA-620 ANALYSER AND A LOWER PT/INR RESULT WAS GENERATED (PT 14.4/INR 1.47). THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH PT/INR PATIENT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7233793 ↗