Roche 9180 Chloride electrode 03110451180Recalls & 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 04015630028719), received between Feb 10, 2025 and Feb 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “High 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
- High Test 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.
MalfunctionFeb 10, 2025High Test Results; High Test Results
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CHLORIDE (CL) ON AN ELECTROLYTE ANALYZER WHEN COMPARED TO A DIFFERENT ANALYZER AT A DIFFERENT LABORATORY. INITIAL RESULT: 115 MMOL/L. REPEAT RESULT: 104 MMOL/L (TESTED ON ANOTHER ANALYZER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21343208 ↗
Other ELECTRODE, ION-SPECIFIC, CHLORIDE devices
- Dimension® QuikLYTE® Multisensor Na+/K+/Cl- 10445058Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION-SPECIFIC, CHLORIDE34 reports
- Chloride Electrode 3003523001Roche Diagnostics GmbH · ELECTRODE, ION-SPECIFIC, CHLORIDE13 reports
- Chloride Electrode 3246353001Roche Diagnostics GmbH · ELECTRODE, ION-SPECIFIC, CHLORIDE13 reports
- Chloride electrode 03246353001Roche Diagnostics GmbH · ELECTRODE, ION-SPECIFIC, CHLORIDE4 reports
- RAPIDLab® 1200 Series 1240 10321840Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION-SPECIFIC, CHLORIDE1 report
- STAT PROFILE PRIME CSSNova Biomedical Corporation · ELECTRODE, ION-SPECIFIC, CHLORIDE1 report
- STAT PROFILE CCXNova Biomedical Corporation · ELECTRODE, ION-SPECIFIC, CHLORIDE1 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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