Chloride electrode 03246353001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613336227787), received between May 13, 2025 and Mar 18, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 CHLORIDE. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE SODIUM RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE POTASSIUM 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 24626127 ↗
• 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 CL. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE K RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE NA 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 23987883 ↗
• 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 CHLORIDE. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER: (B)(6) FOR INFORMATION ON THE SODIUM RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER: (B)(6) FOR INFORMATION ON THE POTASSIUM 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 23830474 ↗
• MalfunctionMay 13, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE SODIUM ELECTRODE RESULTS FOR 12 PATIENT SAMPLES AND QUESTIONABLE CHLORIDE ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 ISE 1800 MODULE. THIS MEDWATCH WILL APPLY TO THE CHLORIDE ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ISE SODIUM ELECTRODE. PATIENT 1: THE INITIAL NA RESULT IS 147 MMOL/L, AND THE REPEATED RESULT WAS 140 MMOL/L. PATIENT 2: THE INITIAL NA RESULT IS 144 MMOL/L, AND THE REPEATED RESULT WAS 134 MMOL/L. PATIENT 3: THE INITIAL NA RESULT IS 152 MMOL/L, AND THE REPEATED RESULT WAS 145 MMOL/L. PATIENT 4: THE INITIAL NA RESULT IS 145 MMOL/L, AND THE REPEATED RESULT WAS 137 MMOL/L. PATIENT 5: THE INITIAL NA RESULT IS 153 MMOL/L, AND THE REPEATED RESULT WAS 146 MMOL/L. PATIENT 6: THE INITIAL NA RESULT IS 150 MMOL/L, AND THE REPEATED RESULT WAS 143 MMOL/L. PATIENT 7: THE INITIAL NA RESULT IS 150 MMOL/L, AND THE REPEATED RESULT WAS 142 MMOL/L. PATIENT 8: THE INITIAL NA RESULT IS 150 MMOL/L, AND THE REPEATED RESULT WAS 142 MMOL/L. PATIENT 9: THE INITIAL NA RESULT IS 151 MMOL/L, AND THE REPEATED RESULT WAS 144 MMOL/L. PATIENT 10: THE INITIAL NA RESULT IS 142 MMOL/L,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013232 ↗

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.