ONLINE TDM Carbamazepine Gen.4 08057435190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613336121108), received between Dec 2, 2025 and Dec 2, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Non Reproducible 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.
Reports received per month
Most reported problems
Device problems
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2025Non Reproducible Results; Non Reproducible Results
THERE WAS AN ALLEGATION OF QUESTIONABLE ONLINE TDM CARBAMAZEPINE GEN.4 RESULTS WITH THREE SAMPLES FROM THE SAME PATIENT TESTED ON A COBAS C 503 ANALYTICAL UNIT. SAMPLE 1: THE SAMPLE WAS TESTED IN A VACUATE LITHIUM/HEPARIN TUBE, AND THE INITIAL RESULT WAS 64.9 G/ML. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 24.1 G/ML AND 19.6 G/ML. SAMPLE 2: THE SAMPLE WAS TESTED IN A VACUETTE LITHIUM/HEPARIN TUBE, AND THE RESULT WAS 18.1 G/ML. SAMPLE 3: THE SAMPLE WAS TESTED IN A VACUETTE DRY/SERUM, AND THE RESULT WAS 17.3 G/ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23697564 ↗
Other ENZYME IMMUNOASSAY, CARBAMAZEPINE devices
- VITROS 8892382Ortho-Clinical Diagnostics, Inc. · ENZYME IMMUNOASSAY, CARBAMAZEPINE6 reports
- IMMULITE® 2000 Systems CMP Carbamazepine 10381550Siemens Healthcare Diagnostics Products Ltd · ENZYME IMMUNOASSAY, CARBAMAZEPINE2 reports
- ONLINE TDM Carbamazepine Gen4 7258062190Roche Diagnostics GmbH · ENZYME IMMUNOASSAY, CARBAMAZEPINE1 report
- ARCHITECT 1P36-27Abbott GmbH · ENZYME IMMUNOASSAY, CARBAMAZEPINE1 report
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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