pH Electrode 3111717180Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630014248), received between Oct 24, 2022 and Oct 24, 2022 — 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.

• MalfunctionOct 24, 2022High Test Results; No Apparent Adverse Event; High Test Results; No Apparent Adverse Event

  THERE WAS AN ALLEGATION OF QUESTIONABLE ROCHE OMNI ELECTRODE PH RESULTS FROM 3 PATIENT SAMPLES ON A COBAS B 221 ROCHE OMNI S6 SYSTEM. FOR SAMPLE 1, THE PH RESULT WAS 7.45. THE RESULT ON AN AVL ANALYZER WAS 7.33. FOR SAMPLE 2, THE PH RESULT WAS 7.39. THE RESULT ON AN AVL ANALYZER WAS 7.28. FOR SAMPLE 3, THE PH RESULT WAS 7.43. THE RESULT ON AN AVL ANALYZER WAS 7.30. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS FROM THE AVL ANALYZER WERE DEEMED CORRECT. THE ELECTRODE SERIAL NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15662816 ↗