Blood Typing Manager 210404Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08436583731215), received between Feb 20, 2026 and Feb 20, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (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 18, 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.

• MalfunctionFeb 20, 2026Computer Software Problem

  CUSTOMER REPORTS THAT THE CROSSMATCH RESULTS FOR SAMPLE 'Y,6.0051211' WITH 2 DIFFERENT DONORS ('B)(6) AND '(B)(6) ARE AUTO VALIDATED WHEN THE SYSTEM IS SETUP TO STOP AUTO VALIDATION FOR ALL CROSSMATCH RESULTS WITH SPECIAL RESULTS NOTICE. THE SYSTEM IS CONFIGURED TO CONSIDER ALL CROSSMATCH RESULTS AS 'SPECIAL RESULTS'. AS STATED IN BTM'S IFU SECTION 7 'CONFIGURABLE FEATURES' SUBSECTION 7.1.1 SPECIAL RESULTS: 'SEVERAL SPECIAL RESULTS CONTROLS ARE AVAILABLE ON THE BLOOD TYPING MANAGER IN ORDER TO CATCH AND SHOW SIGNIFICANT, UNEXPECTED, MODIFIED, RARE OR UNCOMMON RESULTS. RESULTS NOTICES FUNCTION AS A STOPPER FOR AUTO VALIDATION: IF AN ORDER HAS ANY OF THESE NOTICES, IT CANNOT BE AUTO VALIDATED BY THE SYSTEM BUT IT IS REQUIRED TO BE REVIEWED INDIVIDUALLY FROM THE ORDER DETAIL BY THE OPERATOR TO TAKE THE APPROPRIATE ACTIONS. FROM THERE, ORDER CAN BE MANUALLY VALIDATED WITH A MANDATORY NOTE'. HOWEVER, EVEN THOUGH THEY ARE CONFIGURED AS SPECIAL RESULTS, THE SYSTEM AUTO-VALIDATES THEM, PREVENTING THE USER FROM REVIEWING THEM BEFORE EXPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399000 ↗