STAR COMPL. WITH ACCESS. 185080Recalls & reported problems
Hamilton Bonaduz AG · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630032600010), received between Jun 18, 2025 and Mar 20, 2026 — classified as 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Computer Software Problem1
- Misfocusing1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Computer Software Problem
THERE WAS AN ALLEGATION OF SAMPLE ID MISMATCHES WHEN USING THE HAMILTON STAR COMPL. WITH ACCESSORIES POOLER. THE CUSTOMER REPORTED THAT TWO OF THEIR POOLERS INTERMITTENTLY FAIL TO RECOGNIZE THE CORRECT NUMBER OF SAMPLE POOLS, LEADING TO SAMPLE IDS BEING ASSIGNED TO THE WRONG TUBES. ON POOLER SERIAL NUMBER (B)(6), INITIALLY, A BATCH OF (B)(4) SAMPLES WAS LOADED, EXPECTED TO FORM 32 POOLS, BUT ONLY (B)(4) POOLS WERE RECOGNIZED. A SIMILAR ISSUE OCCURRED LATER, WHERE ONLY (B)(4) SAMPLES WERE RECOGNIZED INSTEAD OF 24. ADDITIONALLY, THE SECOND POOLER, SERIAL NUMBER (B)(6), EXHIBITED THE SAME BEHAVIOR. THE CUSTOMER REBOOTED THE POOLER AND PC, WHICH RESOLVED THE ISSUE TEMPORARILY. NO ERRONEOUS RESULTS WERE REPORTED AS THE SAMPLE MISMATCHES WERE RESOLVED AFTER RELOADING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24650366 ↗MalfunctionJun 18, 2025Misfocusing; Misfocusing
THERE WAS AN ALLEGATION OF A MISREADING OF A SAMPLE BARCODE WHEN USING THE HAMILTON STAR COMPL. WITH ACCESSORIES POOLER. IT WAS OBSERVED THAT THE SAMPLE ID (B)(6) WAS INCORRECTLY READ AS (B)(6) DURING THE PP96 REPEAT RUN. THE SAME SAMPLE WAS CORRECTLY READ DURING THE ORIGINAL PP96 RUN. THE SAMPLE WAS READ MULTIPLE TIMES USING THE HAMILTON CEGD20122-H8 ASSOCIATED HANDHELD SCANNER SICK IDM 140-21P06 (B)(6). THE SAMPLE WAS PREDOMINANTLY READ INCORRECTLY. FOR COMPARISON, THE SAMPLE WAS ALSO READ WITH A DEPARTMENT-INTERNAL HANDHELD SCANNER, WHICH CONSISTENTLY READ THE SAMPLE CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22283387 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.