Potassium ElectrodeRecalls & reported problems across all models

We found 4 models of Potassium Electrode by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Aug 22, 2018 and May 8, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “High Test Results” (17 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Potassium Electrode problems

Potassium Electrode models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Potassium Electrode 10825441001

  ELECTRODE, ION SPECIFIC, POTASSIUM
  14 reports
• Potassium electrode 10825441001

  ELECTRODE, ION SPECIFIC, POTASSIUM
  12 reports
• Potassium Electrode 3111628180

  ELECTRODE, ION SPECIFIC, POTASSIUM
  6 reports
• Potassium Electrode 21029355001

  ELECTRODE, ION SPECIFIC, POTASSIUM
  2 reports

Recent Potassium Electrode adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH POTASSIUM RESULTS FOR SEVERAL PATIENTS FROM THE COBAS 6000 C 501 ANALYZER. THE PATIENTS WERE SENT TO THE ER AND REDRAWN. THE RESULTS FOR THE NEW SAMPLES WERE NORMAL POTASSIUM LEVELS. SUBSEQUENTLY, THE CUSTOMER REPEATED THE ORIGINAL SAMPLES ON THEIR OTHER C501 ANALYZER, AND THE RESULTS MATCHED THE INITIAL RESULTS ONE SPECIFIC EXAMPLE WAS PROVIDED: THE INITIAL RESULT WAS 7.3 MMOL/L. THE PATIENT WAS SENT TO THE ER AND REDRAWN. THE RESULT WAS A NORMAL POTASSIUM RESULT. NO SPECIFIC RESULT WAS PROVIDED. THE ORIGINAL SAMPLE WAS THEN REPEATED ON ANOTHER COBAS C501, AND THE REPEAT RESULT MATCHED THE ORIGINAL RESULT OF 7.3 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125356 ↗
• MalfunctionMar 18, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE (NA), POTASSIUM ELECTRODE (K), AND ISE INDIRECT NA-K-CL FOR GEN.2 (CL) RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C (501) MODULE. THIS MEDWATCH WILL COVER POTASSIUM. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT- (B)(6) FOR INFORMATION ON THE SODIUM RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER- (B)(6) FOR INFORMATION ON THE CHLORIDE RESULTS. THE INITIAL NA RESULT WAS 123 MMOL/L, THE INITIAL K RESULT WAS 3.42 MMOL/L, AND THE INITIAL CL RESULT WAS 116.9 MMOL/L. THE CUSTOMER QUESTIONED THE RESULTS AS THEY WERE ACCOMPANIED BY A NEGATIVE ION GAP WHICH PROMPTED THEM TO REPEAT THE RESULTS. THE REPEAT NA RESULT WAS 137 MMOL/L, THE REPEAT K RESULT WAS 4.21 MMOL/L, AND THE REPEAT CL RESULT WAS 102.5 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629397 ↗
• MalfunctionJan 12, 2026High Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE POTASSIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS 8000 COBAS ISE MODULE. INITIAL RESULT: 5.1 MMOL/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT, AND THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: 4.5 MMOL/L. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039565 ↗
• MalfunctionJan 7, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT NA-K-CL FOR GEN.2 (CL), POTASSIUM ELECTRODE (K), AND SODIUM ELECTRODE (NA) RESULTS FOR 5 PATIENT SAMPLES ON A COBAS 8000 COBAS ISE MODULE. THIS MEDWATCH WILL COVER K. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE NA RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CL RESULTS. THE CUSTOMER HAD NOTICED AN INCREASED FREQUENCY OF HIGH RESULTS WHICH PROMPTED THEM TO REPEAT PATIENT SAMPLES. FOR SAMPLE 1, THE INITIAL NA RESULT WAS 167 MMOL/L, THE INITIAL K RESULT WAS 5.2 MMOL/L, AND THE INITIAL CL RESULT WAS 123 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE NA RESULT WAS 141 MMOL/L, THE K RESULT WAS 4.5 MMOL/L, AND THE CL RESULT WAS 108 MMOL/L. FOR SAMPLE 2, THE INITIAL NA RESULT WAS 244 MMOL/L AND THE INITIAL K RESULT WAS 7.8 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER. THE NA RESULT WAS 140 MMOL/L AND THE K RESULT WAS 4.1 MMOL/L. FOR SAMPLE 3, THE INITIAL NA RESULT WAS 220 MMOL/L, THE INITIAL K RESULT WAS 8.4 MMOL/L, AND THE INITIAL CL RESULT WAS 166 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE NA RESULT WAS 131 MMOL/L, THE K RESULT WAS 5.3

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987887 ↗
• MalfunctionDec 17, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT NA-K-CL FOR GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C (501) MODULE. THIS MEDWATCH WILL COVER POTASSIUM. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CHLORIDE RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE SODIUM RESULTS. THE INITIAL NA RESULT WAS 104 MMOL/L, THE INITIAL K RESULT WAS 3.5 MMOL/L, AND THE INITIAL CL RESULT WAS 73.2 MMOL/L. THE CUSTOMER QUESTIONED THE RESULTS WHICH PROMPTED THEM TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER C 501 ANALYZER AND THE NA RESULT WAS 129 MMOL/L, THE K RESULT WAS 4.32 MMOL/L, AND THE CL RESULT WAS 94.3 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830045 ↗
• MalfunctionOct 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR APPROXIMATELY 9 PATIENT SAMPLES TESTED ON A COBAS PRO ISE ANALYTICAL UNIT. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT SAMPLE WITH DISCREPANT POTASSIUM ELECTRODE RESULTS. THE SAMPLE WAS INITIALLY PROCESSED ON A COBAS 8100 PRE-ANALYTICS SYSTEM. THE SAMPLE INITIALLY RESULTED IN A POTASSIUM VALUE OF 5.5 MMOL/L. THE CUSTOMER NOTICED THAT THE SAMPLE WAS NOT CENTRIFUGED. THE SAMPLE WAS THEN CENTRIFUGED AND REPEATED, RESULTING IN A VALUE OF 4.6 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23339298 ↗
• MalfunctionAug 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE POTASSIUM RESULTS FROM THE COBAS B 221 4 ROCHE OMNI S4 SYSTEM. THE SAMPLES WERE REPEATED AFTER THE CUSTOMER CLEANED THE ANALYZER. PATIENT 1 INITIAL RESULT WAS 10.84 MMOL/L, AND THE REPEAT RESULT WAS 4.63 MMOL/L. PATIENT 2 INITIAL RESULT WAS 6.82 MMOL/L, AND THE REPEAT RESULT WAS 3.8 MMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726604 ↗
• MalfunctionJul 29, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE POTASSIUM ELECTRODE RESULTS WITH ONE PATIENT SAMPLE TESTED ON A COBAS 6000 C 501 MODULE. THE INITIAL RESULT WAS 4.02 MMOL/L. THE REPEAT RESULT WAS 4.52 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642383 ↗
• MalfunctionJul 25, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE POTASSIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 12.54 MMOL/L, AND THE REPEATED RESULT WAS 4.14 MMOL/L. THE SAMPLE WAS REPEATED BECAUSE THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL CONDITION. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608312 ↗
• MalfunctionJun 16, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE POTASSIUM ELECTRODE RESULTS FROM THE COBAS 8000 ISE 1800 MODULE. PATIENT 1'S INITIAL RESULT WAS 6.1 MMOL/L, AND THE REPEAT RESULT WAS 4.4 MMOL/L. PATIENT 2'S INITIAL RESULT WAS 5.5 MMOL/L, AND THE REPEAT RESULT WAS 3.8 MMOL/L. THE REPEAT RESULTS WERE FROM ANOTHER ANALYZER AND DEEMED TO BE CORRECT. THE INITIAL RESULTS WERE QUESTIONED BECAUSE OF AN ALARM CODE DURING THE RUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211325 ↗
• MalfunctionJun 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED FOR POTASSIUM (K) ON A COBAS B221 6 ROCHE OMNI S6 SYSTEM. PATIENT 1 AND PATIENT 2 WERE INITIALLY TESTED (TUBE 1) WITH AN ARTERIAL BLOOD GAS (ABG) TEST ON A COBAS B221, WHILE SIMULTANEOUSLY, VENOUS BLOOD SAMPLES (TUBE 2) WERE DRAWN FROM PATIENT 1 AND PATIENT 2 AND TESTED ON DIFFERENT ANALYZERS. PATIENT 1: TUBE 1 RESULT: 2.61 MMOL/L. TUBE 2 RESULT: 4.2 MMOL/L (TESTED ON A BECKMAN COULTER AU5800 INSTRUMENT). PATIENT 2 WAS TESTED ON (B)(6) 2025: TUBE 1 RESULT: 3.74 MMOL/L. TUBE 2 RESULT: 4.7 MMOL/L (TESTED ON A C503 ANALYZER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206167 ↗
• MalfunctionMay 30, 2025Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 6 PATIENTS¿ SAMPLES TESTED ON A COBAS 6000 C501 (UL) V MODULE. RESULTS FOR THE POTASSIUM (K) TEST WERE AFFECTED. PATIENT 1: INITIAL RESULT: 3.0 MMOL/L. REPEAT RESULT: 4.5 MMOL/L. PATIENT 2: INITIAL RESULT: 3.8 MMOL/L. REPEAT RESULT: 4.8 MMOL/L. PATIENT 3: INITIAL RESULT: 4.4 MMOL/L. REPEAT RESULT: 4.9 MMOL/L. PATIENT 4: INITIAL RESULT: 5.5 MMOL/L. REPEAT RESULT: 4.5 MMOL/L. PATIENT 5: INITIAL RESULT: 6.7 MMOL/L. REPEAT RESULT: 4.5 MMOL/L. PATIENT 6: INITIAL RESULT: 3.1 MMOL/L. REPEAT RESULT: 3.91 MMOL/L. THE MEDICAL PROVIDERS QUESTIONED THE INITIAL RESULTS, AND THE SAMPLES WERE REPEATED ON A DIFFERENT COBAS ANALYZER. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. REPORTEDLY, AMENDED REPORTS WITH THE CORRECT RESULTS WERE ISSUED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116555 ↗
• MalfunctionMay 19, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FROM 2 SAMPLES DRAWN AT THE SAME TIME FROM 1 PATIENT TESTED FOR POTASSIUM ELECTRODE (K) ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.3 MMOL/L. THIS SAMPLE WAS COLLECTED WITH A SYRINGE FROM THE PATIENT¿S IV PORT. THE DOCTOR QUESTIONED THIS RESULT. THE CUSTOMER REPEATED THIS SAMPLE, AND THE RESULT WAS 6.6 MMOL/L. ANOTHER SAMPLE WAS COLLECTED AT THE SAME TIME AS THE SAMPLE FROM THE IV PORT, AND THE INITIAL RESULT WAS 4.35 MMOL/L. A NEW VENOUS SAMPLE WAS OBTAINED, AND THE RESULT WAS 4.1 MMOL/L. THE CUSTOMER REPEATED THIS SAMPLE, AND THE RESULT WAS 4.28 MMOL/L. THE RESULT OF 4.1 MMOL/L WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044977 ↗
• MalfunctionMay 6, 2025Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED FOR POTASSIUM ELECTRODE (K) ON A COBAS 6000 C (501) MODULE. PATIENT 1 INITIAL K RESULT WAS 6.1 MMOL/L. THIS RESULT DID NOT CORRESPOND TO THE PATIENT¿S PREVIOUS K RESULT, AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 5.0 MMOL/L. PATIENT 2 INITIAL K RESULT WAS 6.5 MMOL/L. THE CUSTOMER NOTICED THAT QC FAILED AFTER THE INITIAL RESULT AND REPEATED THE SAMPLE. THE REPEAT RESULT WAS 5.91 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969252 ↗
• MalfunctionJul 23, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 1 PATIENT PLASMA SAMPLE TESTED ON A COBAS C303 ANALYTICAL UNIT. RESULTS FOR THE POTASSIUM (K) TEST WERE AFFECTED. INITIAL RESULT: 6.06 MMOL/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT. THE PATIENT WENT TO THE ER FOR THE NEW SAMPLE COLLECTION WHICH RESULTED IN A K VALUE OF 3.9 MMOL/L. THE CUSTOMER THEN REPEATED THE ORIGINAL SAMPLE ON THE SAME ANALYZER AND THE REPEAT RESULT WAS 4.30 MMOL/L. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810802 ↗

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