BFT II Analyzer 10458677Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768024887), received between Mar 8, 2022 and Mar 8, 2022 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2022High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BFT II ANALYZER USING THROMBOREL S REAGENT. THE SAMPLE WAS REPEATED FOR INR TWO ADDITIONAL TIMES USING THE SAME ANALYZER AND REAGENT, ALSO RECOVERING FALSELY ELEVATED. THE FALSELY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAME SAMPLE WAS RERUN FOR INR AT AN ALTERNATE HOSPITAL USING AN UNKNOWN SYSTEM AND REAGENT, RECOVERING LOWER. THE LOWER RESULT WAS CONSIDERED TO BE THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT INR RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691218 ↗