ADVIA® Chemistry TOB_2 Tobramycin_2 Reagents 10376932Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Tobramycin - ADVIA Chem. - RGT - 4x100 tests · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00630414561677), received between Apr 15, 2024 and Apr 17, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “High Test Results” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- High Test Results2
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.
MalfunctionApr 17, 2024High Test Results; High Test Results
THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED TOBRAMYCIN_2 (TOB_2) RESULT ON A NEONATAL PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT SYSTEM. THE ERRONEOUSLY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ADVIA CHEMISTRY XPT SYSTEM. ALSO, A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON THE ORIGINAL ADVIA CHEMISTRY XPT SYSTEM. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TOBRAMYCIN_2 (TOB_2) RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19125037 ↗MalfunctionApr 15, 2024High Test Results; High Test Results
A FALSELY ELEVATED TOBRAMYCIN_2 (TOB_2) PATIENT SAMPLE RESULT WAS OBTAINED UPON REPEAT ON AN ADVIA® CHEMISTRY XPT SYSTEM. THE REPEAT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S) THE INITIAL, LOWER RESULT WAS CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TOBRAMYCIN_2 (TOB_2) RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19110264 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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