Trinity Biotech Premier Hb9210 HbA1c Analyzer - 1 eachRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05391516744751), received between May 1, 2025 and May 1, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unexpected Therapeutic 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 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.

• MalfunctionMay 1, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON (B)(6) 2025, THE CUSTOMER STATED THAT THEY OBSERVED ERROR CODES DURING ONE SHIFT WHILE OPERATING THE PREMIER HB9210 HBA1C SYSTEM, AND THE SAMPLES WERE LEFT FOR THE NEXT SHIFT TO RUN. THE NEXT SHIFT RAN THE QC, WHICH FAILED. THEY THEN PROCEED TO REPLACE THE COLUMNS ON TO THE SYSTEM, RECALIBRATED, AND THEN RAN QC. WITH PASSING QC, PATIENT SAMPLES WERE RAN AND IT WAS OBSERVED THAT 70% OF THE SAMPLES DID NOT MEET "MATCHING" CRITERIA BETWEEN PREMIER HB9210 ANALYZERS. THE CUSTOMER STATES THAT THEIR CRITERIA IS THE SAMPLES MUST MATCH WITHIN 8%, BUT THEY SAID THEY OBSERVED 15-30% VARIATION BETWEEN THE SAMPLES RAN ON THE DIFFERENT ANALYZERS. THE CUSTOMER STATES THAT THEY PERFORMED A LOOK BACK ON PREVIOUSLY RAN PATIENT RESULTS AND OBSERVED 800 SAMPLES THAT DID NOT MEET THEIR "MATCHING" CRITERIA AND THE TESTS WERE REPEATED. TRINITY BIOTECH ARE NOT ABLE TO CONFIRM IF THE PATIENT DATA WAS AUTOMATICALLY RELEASED FROM THEIR LABORATORY INFORMATION SYSTEM (LIS). THE CUSTOMER STATED THAT A NOTIFICATION WAS SENT FOR THE 800 POTENTIALLY DISCREPANT RESULTS. BASED ON THESE NOTIFICATIONS, THE CUSTOMER CLAIMS THAT THEY HAVE BEEN ADVISED THAT SOME PATIENTS HAD BEEN INCORRECTLY PRESCRIBED MEDICATION. CUR

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21945095 ↗