Potassium electrode 10825441001 (UDI 07613336227770)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613336227770), received between May 6, 2025 and May 8, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 reports).

10 other recalls cover devices cleared under the same FDA submission (K060373); they may or may not involve this specific model.

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 12 most recent of 12 reports, 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 ↗
• 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 ↗
• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060373. One submission often covers many models, so check the product and lot details in each record.

• Z-2476-2019 · Jul 18, 2019 · Terminated
  cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
• Z-1268-2018 · Dec 18, 2017 · Terminated
  c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 0503634
• Z-0909-2018 · Jul 18, 2017 · Terminated
  cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL +
• Z-0378-2018 · Jun 29, 2017 · Terminated
  Brand Name: cobas c 6000 MODULAR Series System e 601 cobas c 8000 MODULAR Series System - e 602 Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number
• Z-2049-2017 · Mar 21, 2017 · Terminated
  Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: Th
• Z-0096-2017 · Jul 15, 2016 · Terminated
  cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primar
• Z-1792-2014 · May 21, 2014 · Terminated
  cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay
• Z-1791-2014 · May 21, 2014 · Terminated
  cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay
• Z-0542-2009 · Sep 15, 2008 · Terminated
  Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.
• Z-0576-2008 · Dec 4, 2007 · Terminated
  Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.