Roche 9180 Potassium electrode 03110338180Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630028689), received between Aug 12, 2025 and Aug 12, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR SODIUM (NA) AND POTASSIUM (K) ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE INITIAL NA RESULT WAS 151 MMOL/L. THE REPEAT RESULT WAS 133 MMOL/L. THE INITIAL K RESULT WAS 4.9 MMOL/L. THE REPEAT RESULT WAS 4.2 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786997 ↗