N Antisera to Human IgM 10446303Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768009846), received between Sep 1, 2017 and Sep 1, 2017 — classified as 1 malfunction.

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.

• MalfunctionSep 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FLAGGED HIGH IMMUNOGLOBULIN M (IGM) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE BN II SYSTEM. THE SAME PATIENT SAMPLE WAS DILUTED USING MULTIPLE DILUTION RATIOS AND RUN ON THE SAME BN II SYSTEM. DIFFERENT IGM RESULTS WERE OBTAINED ON THESE SAMPLES AND THE RESULTS WERE DILUTION RATIO DEPENDENT. THE SAME PATIENT SAMPLE WAS RESPUN AND RUN WITH MULTIPLE DILUTIONS ON AN ALTERNATE BN II SYSTEM. THE RESULTS OBTAINED ON THE ALTERNATE BN II SYSTEM MATCHED THE RESULTS OBTAINED ON THE ORIGINAL SYSTEM. AN IGM RESULT OF 508.0 MG/DL WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER INDICATED THAT THE CORRECT RESULT FOR THIS PATIENT IS UNKNOWN SINCE THEY DO NOT HAVE THE PATIENT'S CLINICAL HISTORY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FLAGGED HIGH IGM RESULT ON THIS PATIENT SAMPLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6840149 ↗