Roche 9180 Lithium Electrode 3110664180Recalls & 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 04015630028795), received between Mar 1, 2024 and Mar 1, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test 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
- Low Test Results1
- 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.
MalfunctionMar 1, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE LITHIUM ELECTRODE (LI+) ON A 9180 ELECTROLYTE ANALYZER. THE FIRST SAMPLE INITIALLY RESULTED IN A LITHIUM VALUE OF 0.23 MMOL/L AND IT REPEATED AS 0.29 MMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A VALUE OF 0.69 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A LITHIUM VALUE OF 0.53 MMOL/L ON (B)(6) 2024. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2024, RESULTING IN LITHIUM VALUES OF 1.79 MMOL/L AND 1.53 MMOL/L.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18818742 ↗
Other FLAME PHOTOMETRY, LITHIUM devices
- VITROS 1632660Ortho-Clinical Diagnostics, Inc. · FLAME PHOTOMETRY, LITHIUM4 reports
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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