N/A 340183Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382903401833), received between Feb 13, 2023 and Jul 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS DURING USE WITH THE BD® HLA-B27 KIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT LOT NUMBER 2349915 HAD ALMOST ALL POSITIVE RESULTS FALLING INTO THE GRAY ZONE, REQUIRING CONFIRMATION THROUGH PCR AND ALL ARE CONFIRMED HLA-B27 POSITIVE, THIS HAPPENED FOR 2-3 DAYS. AFTER SWITCHING TO LOT 3096158 AND CONDUCTING A COMPARISON, THE NEW BATCH SHOWED POSITIVE RESULTS. HOWEVER, THE FLUORESCENCE INTENSITY OF THE OLD BATCH(2349915) STILL REMAINED IN THE GRAY ZONE. PLEASE REFER TO THE ATTACHED RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17386190 ↗
• MalfunctionFeb 13, 2023Non Reproducible Results; Non Reproducible Results

  IT WAS REPORTED THAT WHILE USING THE BD® HLA-B27 KIT THAT THERE WERE ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR MOLECULAR PATHOLOGY DEPARTMENT RAN SOME OF OUR SAMPLES THAT WERE NEGATIVE FOR HLA-B27 BY FLOW CYTOMETRY AS PART OF THEIR VALIDATION OF THE LAMP MOLECULAR TEST (100% SPECIFICITY). 2 OUT OF THE FOUR FLOW NEGATIVE SAMPLES HAVE COME BACK POSITIVE BY LAMP. WE ARE TESTING MORE NEGATIVE FLOW SAMPLES TO GET AN IDEA OF THE EXTENT OF THE PROBLEM BUT EARLY SIGNS SUGGEST THIS IS GOING TO LEAD TO A LOT OF PATIENTS BEING RECALLED FOR TESTING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363437 ↗