Chloride Electrode 3003523001Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08430215015353), received between Aug 10, 2018 and Nov 12, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECTRODE T7, CHLORIDE RESULTS FROM SEVERAL PATIENT SAMPLES TESTED ON THE COBAS INTEGRA 400 PLUS. ONE EXAMPLE OF A QUESTIONABLE RESULT WAS PROVIDED: THE INITIAL RESULT FROM THE ANALYZER WAS 116.5 MMOL/L. THE REPEAT RESULT FROM ANOTHER COBAS INTEGRA 400 PLUS ANALYZER WAS 105.4 MMOL/L. THE REPORTER NOTED AN ANION GAP OF -3, PROMPTING THE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532787 ↗
• MalfunctionJul 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE CHLORIDE (CL) TEST RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENTS' SAMPLES TESTED ON THE ROCHE 9180 ELECTROLYTE ANALYZER. THE REPORTER STATED THAT THE RESULTS DID NOT MATCH THE PATIENTS' CLINICAL PICTURES. THE REPORTER PROVIDED THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS: PATIENT 1: INITIAL RESULT: 107.8 MMOL/L. REPEAT RESULT: 104.8 MMOL/L. PATIENT 2: INITIAL RESULT: 107.4 MMOL/L. REPEAT RESULT: 103.8 MMOL/L. PATIENT 3: INITIAL RESULT: 111.3 MMOL/L. REPEAT RESULT: 113.0 MMOL/L. PATIENT 4: INITIAL RESULT: 110.6 MMOL/L. REPEAT RESULT: 107.4 MMOL/L. PATIENT 5: INITIAL RESULT: 105 MMOL/L. REPEAT RESULT: 108.3 MMOL/L. ON (B)(6) 2025: PATIENT 6: INITIAL RESULT: 111.1 MMOL/L. REPEAT RESULT: 111.2 MMOL/L. ON (B)(6) 2025: PATIENT 7: INITIAL RESULT: 112.5 MMOL/L. REPEAT RESULT: 112.2 MMOL/L. PATIENT 8: INITIAL RESULT: 112.9 MMOL/L. REPEAT RESULT: 113.2 MMOL/L. PATIENT 9: INITIAL RESULT: 112 MMOL/L. REPEAT RESULT: 112.1 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668196 ↗
• MalfunctionFeb 16, 2024Output Problem; Output Problem

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE CHLORIDE ELECTRODE ON A COBAS INTEGRA 400 PLUS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE RESULTED IN A CL VALUE OF 120 MMOL/L WHEN TESTED ON THE INTEGRA 400 PLUS ANALYZER. THE SAMPLE WAS REPEATED ON AN UNKNOWN GASOMETER INSTRUMENT, RESULTING IN A CL VALUE OF 109 MMOL/L. THIS VALUE WAS CONSIDERED TO BE CORRECT BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720798 ↗
• MalfunctionFeb 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT CI FOR GEN.2 RESULTS FROM 20 PATIENT SAMPLES TESTED ON THE COBAS INTEGRA 400 PLUS. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER NOTED THAT THE CL RESULTS WERE RUNNING HIGH COMPARED TO THE PATIENT HISTORY PROMPTING THE RERUN OF THE PATIENT SAMPLES. THE REPORTER WAS ABLE TO PROVIDE TWO EXAMPLES OF DISCREPANT RESULTS: SAMPLE 1 THE INITIAL CL RESULT WAS 122 MMOL/L. THE REPEAT RESULT WAS 105 MMOL/L. SAMPLE 2 THE INITIAL CL RESULT WAS 118 MMOL/L. THE REPEAT RESULT WAS 106 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693992 ↗
• MalfunctionAug 25, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR CL RESULTS FOR 3 PATIENT SAMPLES ON A COBAS INTEGRA 400 PLUS. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLES AS THEIR AFTERNOON QC WAS OUT OF RANGE, THE RESULTS DID NOT MEET THEIR CLINICAL PICTURES, AND THEY QUESTIONED THE HIGH RESULTS. ON (B)(6) 2023, SAMPLE ID (B)(6) HAD AN INITIAL CL RESULT OF 146 MMOL/L. THE REPEAT RESULT WAS 104 MMOL/L. ON (B)(6) 2023, SAMPLE ID (B)(6) HAD AN INITIAL CL RESULT OF 185 MMOL/L. THE REPEAT RESULT WAS 107 MMOL/L. ON (B)(6), SAMPLE ID (B)(6) HAD AN INITIAL CL RESULT OF 139 MMOL/L. THE REPEAT RESULT WAS 104 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 17627079 ↗
• MalfunctionJul 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER QUESTIONED HIGH RESULTS FOR 4 PATIENT SAMPLES TESTED FOR CHLORIDE ELECTRODE (CL) ON A COBAS INTEGRA 400 PLUS. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 138 MMOL/L. THE SAMPLE WAS REPEATED 3 TIMES WITH RESULTS OF 119 MMOL/L, 126 MMOL/L, AND 239 MMOL/L. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT. THE RESULTS FOR THIS PATIENT WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376138 ↗
• MalfunctionJun 5, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR CL RESULTS FOR 1 PATIENT SAMPLE ON A COBAS INTEGRA 400 PLUS. THE INITIAL CL ALIQUOT RESULT WAS 88 MMOL/L. AS THE RESULT WAS LOW, THIS PROMPTED THE CUSTOMER TO RERUN QC. THE QC WAS OUT OF RANGE AND THE CUSTOMER PERFORMED TROUBLESHOOTING TO GET THE QC WITHIN RANGE. WHEN QC WAS BACK WITHIN RANGE, THE CUSTOMER REPEATED THE PATIENT SAMPLE ALIQUOT AND THE REPEAT RESULT WAS 101 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS DEEMED CORRECT. THE ANALYZER SERIAL NUMBER IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17063826 ↗
• MalfunctionMay 9, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN CHLORIDE RESULTS FROM COBAS INTEGRA 400 PLUS ANALYZER SERIAL NUMBER (B)(6) . SAMPLE 1 INITIAL RESULT WAS 141 MMOL/L AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR CALLED QUESTIONING THE RESULT. THE REPEAT RESULT WAS 109 MMOL/L. ON (B)(6) 2023, SAMPLE 2 INITIAL RESULT WAS 136 MMOL/L AND THE REPEAT RESULT WAS 108. THE QUESTIONABLE RESULT FOR THIS SAMPLE WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896505 ↗
• MalfunctionSep 27, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CHLORIDE ELECTRODE RESULTS FROM 1 PATIENT ON A COBAS INTEGRA 400 PLUS. THE INITIAL CL RESULT WAS 85 MMOL/L. THE REPEAT RESULTS WERE 112 MMOL/L, 109 MMOL/L, AND 108 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS OF 109 MMOL/L AND 108 MMOL/L 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 15491042 ↗
• MalfunctionSep 19, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE CHLORIDE ELECTRODE ON A COBAS INTEGRA 400 PLUS WITH SERIAL NUMBER (B)(4). THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLES WERE SENT OUT FOR RERUNS TO ANOTHER SITE THAT USES A COBAS C303. ON (B)(6) 2022, THE PATIENT SAMPLES HAD THE FOLLOWING RESULTS: PATIENT SAMPLE 1 - THE INITIAL RESULT FROM THE ANALYZER USING THE REPORTED ELECTRODE LOT WAS 135 MMOL/L. THE REPEAT RESULT FROM THE OTHER SITE WAS 103 MMOL/L. PATIENT SAMPLE 2 - THE INITIAL RESULT FROM THE ANALYZER USING THE REPORTED ELECTRODE LOT WAS 121 MMOL/L. THE FIRST REPEAT RESULT FROM THE OTHER SITE WAS 107 MMOL/L. BECAUSE OF THE DIFFERENCE IN THE PATIENT SAMPLE RESULTS, THE CUSTOMER CHANGED THE CHLORIDE ELECTRODE WITH A NEW ELECTRODE LOT. THE CALIBRATION WAS NOT WITHIN SPECIFICATIONS SO THEY REINSTALLED THE PREVIOUS ELECTRODE. ON (B)(6) 2022, THE ION-SELECTIVE ELECTRODE (ISE) CHECK FAILED. THE CHLORIDE ELECTRODE WAS AGAIN CHANGED WITH A NEW ELECTRODE LOT. THE CALIBRATION WAS WITHIN SPECIFICATIONS. PATIENT SAMPLE 2'S SECOND REPEAT RESULT FROM THE ANALYZER USING THE NEW ELECTRODE LOT WAS 108 MMOL/L. THE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447140 ↗
• MalfunctionJun 6, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE CHLORIDE ELECTRODE ON A COBAS INTEGRA 400 PLUS (SERIAL NUMBER (B)(4)). THE SAMPLE INITIALLY RESULTED IN A CHLORIDE VALUE OF 142 MMOL/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 115 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT AND A CORRECTED REPORT WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600728 ↗
• MalfunctionMar 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN.2 RESULTS FROM THE COBAS INTEGRA 400+ ANALYZER. PATIENT SAMPLE 1 INITIAL SODIUM RESULT WAS 151 MMOL/L. THE PATIENT WAS SENT TO THE ER FOR A NEW SAMPLE TO BE DRAWN AND THE RESULT WAS 144 MMOL/L. THE ORIGINAL SAMPLE WAS REPEATED ON A COBAS 6000 ANALYZER AND THE RESULT WAS 143 MMOL/L. PATIENT 2 INITIAL SODIUM RESULT WAS 149 MMOL/L AND THE REPEAT RESULT WAS 140 MMOL/L. PATIENT 3 INITIAL SODIUM RESULT WAS 148 MMOL/L AND THE REPEAT RESULT WAS 140 MMOL/L. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE ELECTRODE LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13769162 ↗
• MalfunctionAug 10, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF HIGH RESULTS FOR MULTIPLE PATIENTS TESTED FOR CHLORIDE (CL) ON TWO COBAS INTEGRA 400 PLUS INSTRUMENTS WITH SERIAL NUMBERS (B)(4). THE CUSTOMER PROVIDED DATA FOR 11 PATIENT SAMPLES TESTED ON THE INTEGRA 400 PLUS INSTRUMENTS COMPARED TO A COBAS 8000 ISE MODULE. BASED ON THE DATA PROVIDED, THE RESULTS FOR 3 PATIENT SAMPLES WERE DISCREPANT. IT IS NOT CLEAR IF THIS DATA WAS GENERATED FOR DIAGNOSTIC PURPOSES OR IF IT WAS GENERATED FOR TROUBLESHOOTING ONLY. CLARIFICATION ON THIS WAS REQUESTED BUT NOT PROVIDED. PATIENT 1 INITIAL CL RESULT ON AN INTEGRA 400 PLUS INSTRUMENT WAS 103 MMOL/L. THE REPEAT RESULT FROM THE ISE MODULE WAS 103 MMOL/L. PATIENT 2 INITIAL CL RESULT ON AN INTEGRA 400 PLUS INSTRUMENT WAS 112 MMOL/L. THE REPEAT RESULT FROM THE ISE MODULE WAS 101 MMOL/L. PATIENT 3 INITIAL CL RESULT ON AN INTEGRA 400 PLUS INSTRUMENT WAS 113 MMOL/L. THE REPEAT RESULT FROM THE ISE MODULE WAS 102 MMOL/L. IT IS NOT CLEAR WHICH INTEGRA 400 PLUS INSTRUMENT SERIAL NUMBER WAS USED FOR THE INITIAL TESTS. BOTH INSTRUMENTS USED THE SAME CL ELECTRODE LOT NUMBER. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7772495 ↗