Ethanol Gen2 5967104190Recalls & 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 04015630927678), received between Apr 25, 2024 and Apr 25, 2024 — 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.
MalfunctionApr 25, 2024Non Reproducible Results; Non Reproducible Results
THE INITIAL REPORTER RECEIVED A QUESTIONABLE ETHANOL GEN.2 RESULT FOR ONE PATIENT TESTED ON A COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS REPORTED TO THE EMERGENCY ROOM. THE DOCTOR QUESTIONED THE RESULT AS THE PATIENT SMELLED OF ALCOHOL AND THE PATIENT'S COMPANION CONFIRMED THE AMOUNT OF ALCOHOL THE PATIENT TOOK, PROMPTING THE REPORTER TO RERUN THE QC AND THE PATIENT SAMPLE. THE INITIAL RESULT WITH THE PATIENT SAMPLE IN A SAMPLE CUP WAS 6.5 MG/DL (NEGATIVE). THE FIRST REPEAT RESULT USING THE PRIMARY TUBE WAS >300 MG/DL (326.3 MG/DL). THE SECOND REPEAT WITH THE PATIENT SAMPLE IN A SAMPLE CUP WAS >300 MG/DL (336.3 MG/DL). THE RESULT OF A NEW PATIENT SAMPLE WAS >300 MG/DL (309.7MG/DL).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19182805 ↗
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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