Chloride Electrode 3246353001Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08430215043561), received between Sep 12, 2018 and Oct 9, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Low 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionOct 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS 6000 C (501) MODULE WHEN COMPARED TO AN INTEGRA 400 PLUS ANALYZER. RESULTS FOR THE FOLLOWING TESTS WERE AFFECTED: SODIUM (NA) AND CHLORIDE (CL). NA: INITIAL RESULT: 123 MMOL/L. REPEAT RESULT: 137 MMOL/L (TESTED ON INTEGRA 400 PLUS). CL: INITIAL RESULT: 81.7 MMOL/L. REPEAT RESULT: 95 MMOL/L (TESTED ON INTEGRA 400 PLUS). THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THEY DID NOT MATCH THE PATIENT'S HISTORY. THE SAMPLE WAS THEN REPEATED AND THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. REPORTEDLY, THE CUSTOMER CALLED THE PHYSICIAN AND CORRECTED THE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409088 ↗
• MalfunctionJul 18, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA AND CL RESULTS FOR 1 PATIENT PLASMA SAMPLE ON A COBAS 6000 C (501) MODULE. THIS MEDWATCH WILL COVER CL. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE NA RESULTS. THE INITIAL NA RESULT WAS 119 MMOL/L AND THE INITIAL CL RESULT WAS 118.2 MMOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AS THEY WERE DEEMED CRITICAL AND WAS PROMPTED TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER C501 ANALYZER AND THE NA RESULT WAS 136 MMOL/L AND THE CL RESULT WAS 102 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 19773120 ↗
• MalfunctionJun 11, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED ON A COBAS C 303 ANALYTICAL UNIT. SAMPLE 1 HAD DISCREPANT RESULTS WHEN TESTED WITH THE NA ELECTRODE AND CL ELECTRODE. THIS MEDWATCH WILL APPLY TO THE CL ELECTRODE. REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE NA ELECTRODE. SAMPLE 1 ALSO HAD DISCREPANT RESULTS WHEN TESTED WITH THE ELECSYS TROPONIN T GEN 5 ON A COBAS PURE E 402 ANALYTICAL UNIT. REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TROPONIN T ASSAY. SAMPLE 2 HAD DISCREPANT RESULTS WHEN TESTED WITH THE NA ELECTRODE, K ELECTRODE, CL ELECTRODE, AND CALCIUM GEN.2. THIS MEDWATCH WILL APPLY TO THE CL ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE NA ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE K ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CALCIUM ASSAY. A PHYSICIAN QUESTIONED THE INITIAL SAMPLE VALUES SO THE SAMPLES WERE REPEATED. NEITHER THE INITIAL OR REPEAT VALUES WERE DEEMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511492 ↗
• MalfunctionMar 4, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN 2 RESULTS FROM THE COBAS 6000 C 501. THE INITIAL SODIUM RESULT WAS 105 MMOL/L WITH A DATA FLAG AND THE REPEAT RESULT WAS 137 MMOL/L. THE INITIAL CHLORIDE RESULT WAS 131.1 MMOL/L WITH A DATA FLAG AND THE REPEAT RESULT WAS 98.4 MMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18831713 ↗
• MalfunctionFeb 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE NA ELECTRODE, K, AND CL RESULTS FOR 1 SAMPLE, QUESTIONABLE NA ELECTRODE, K RESULTS FOR 1 SAMPLE, AND QUESTIONABLE NA ELECTRODE RESULTS FOR 4 SAMPLES ON A COBAS 6000 C 501 MODULE. SAMPLE 1: (B)(6). THE INITIAL NA RESULT WAS 124 MMOL/L AND THE REPEATED RESULT WAS 138 MMOL/L. THE INITIAL K RESULT WAS 3.90 MMOL/L AND THE REPEATED RESULT WAS 4.45 MMOL/L. THE INITIAL CL RESULT WAS 88.6 MMOL/L AND THE REPEATED RESULT WAS 98.4 MMOL/L. SAMPLE 2: (B)(6). THE INITIAL NA RESULT WAS 123 MMOL/L AND THE REPEATED RESULT WAS 137 MMOL/L. THE INITIAL K RESULT WAS 3.86 MMOL/L AND THE REPEATED RESULT WAS 4.28 MMOL/L. SAMPLE 3: (B)(6). THE INITIAL NA RESULT WAS 130 MMOL/L AND THE REPEATED RESULT WAS 140 MMOL/L. SAMPLE 4: (B)(6). THE INITIAL NA RESULT WAS 133 MMOL/L. AND THE REPEATED RESULT WAS 142 MMOL/L. SAMPLE 5: (B)(6). THE INITIAL NA RESULT WAS 128 MMOL/L AND THE REPEATED RESULT WAS 135 MMOL/L. SAMPLE 6: (B)(6). THE INITIAL NA RESULT WAS 130 MMOL/L AND THE REPEATED RESULT WAS 138 MMOL/L. THE REPEATED RESULTS WERE OBTAINED USING AN ALTERNATE INSTRUMENT AND THEY WERE BELIEVED TO BE CORRECT. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18670752 ↗
• MalfunctionNov 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CL ELECTRODE (CL) AND SODIUM ELECTRODE (NA) ON A COBAS 6000 C (501) MODULE. THIS MEDWATCH WILL COVER CL. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE NA RESULTS. THE INITIAL CL RESULT WAS 135 MMOL/L. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 101 MMOL/L AND 100 MMOL/L. A NEW SAMPLE WAS OBTAINED AND THE CL RESULT WAS 102 MMOL/L. THE INITIAL NA RESULT WAS 110 MMOL/L. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 139 MMOL/L. A NEW SAMPLE WAS OBTAINED AND THE NA RESULT WAS 140 MMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172862 ↗
• MalfunctionNov 14, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 3 PATIENT SAMPLES TESTED FOR CL ELECTRODE (CL) AND NA ELECTRODE (NA) ON A COBAS PRO ISE ANALYTICAL UNIT. THIS MEDWATCH WILL COVER CL. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE NA RESULTS. PATIENT 1: THE INITIAL NA RESULT WAS 157 MMOL/L. THE REPEAT RESULT WAS 140.7 MMOL/L. THE INITIAL CL RESULT WAS 114 MMOL/L. THE REPEAT RESULT WAS 102.3 MMOL/L. PATIENT 2: THE INITIAL NA RESULT WAS 161 MMOL/L. THE REPEAT RESULT WAS 143.2 MMOL/L. THE INITIAL CL RESULT WAS 118 MMOL/L. THE REPEAT RESULT WAS 104.2 MMOL/L. PATIENT 3: THE INITIAL NA RESULT WAS 167 MMOL/L. THE REPEAT RESULT WAS 157.2 MMOL/L. THE INITIAL CL RESULT WAS 136 MMOL/L. THE REPEAT RESULT WAS 122.6 MMOL/L. THE CUSTOMER NOTICED THE INITIAL RESULTS DID NOT MATCH THE PATIENT¿S PREVIOUS HISTORY AND REPEATED THE SAMPLES ON A DIFFERENT ANALYZER. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133648 ↗
• MalfunctionOct 19, 2023Degraded; Mechanical Problem; Material Integrity Problem; Non Reproducible Results; Degraded; Mechanical Problem; Material Integrity Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF ANALYZER ALARMS AND QUESTIONABLE ISE INDIRECT GEN 2 RESULTS FROM THE COBAS 6000 C 501 MODULE. THE INITIAL CHLORIDE RESULT WAS 6088.1 MMOL/L AND THE REPEAT RESULT WAS 100.1 MMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17964232 ↗
• MalfunctionAug 11, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED FOR SODIUM (NA) AND CHLORIDE (CL) ON A COBAS 6000 C (501) MODULE. THIS MEDWATCH WILL COVER CL. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT-83076 FOR INFORMATION ON THE NA RESULTS. PATIENT 1 INITIAL NA RESULT WAS 120 MMOL/L. THE REPEAT RESULT WAS 133 MMOL/L. PATIENT 2 INITIAL NA RESULT WAS 122 MMOL/L. THE REPEAT RESULT WAS 132 MMOL/L. PATIENT 2 INITIAL CL RESULT WAS 87.6 MMOL/L. THE REPEAT RESULT WAS 97.1 MMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515303 ↗
• MalfunctionJan 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ISE INDIRECT GEN 2 CHLORIDE RESULT FROM THE COBAS 8000 COBAS ISE MODULE. THE INITIAL RESULT WAS 85 MMOL/L AND THE REPEAT RESULT WAS 105 MMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245963 ↗
• MalfunctionJan 4, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR "ABOUT 60" PATIENT SAMPLES TESTED WITH ISE INDIRECT NA AND CL FOR GEN.2 ON A COBAS 6000 C (501) MODULE. THE PATIENT SAMPLES WERE REPEATED AS A DOCTOR COMPLAINED ABOUT THE "TOO HIGH" INITIAL RESULTS. ACCORDING TO THE REPORTER, THE INITIAL RESULTS HAD A NA VALUE IN THE "150S" AND REPEATED WITH VALUES IN THE "130S" THE FOLLOWING DAY. THE FOLLOWING EXAMPLE FOR ONE PATIENT SAMPLE WAS PROVIDED BY THE CUSTOMER: THE SAMPLE INITIALLY RESULTED IN A NA VALUE OF 156 MMOL/L AND REPEATED AS 134 MMOL/L THE FOLLOWING DAY. THE SAMPLE INITIALLY RESULTED IN A CL VALUE OF 115 MMOL/L AND REPEATED AS 97 MMOL/L THE FOLLOWING DAY. THE INITIAL QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE NA AND CL ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16098066 ↗
• MalfunctionNov 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 COBAS ISE MODULE. THE INITIAL NA RESULT WAS 116 MMOL/L. THE CUSTOMER QUESTIONED THE RESULT AND REPEATED THE SAMPLE. THE REPEAT RESULT WAS 126 MMOL/L. A NEW SAMPLE WAS COLLECTED AND TESTED ON ANOTHER MODULE. THE NA RESULTS WERE 119 MMOL/L AND 120 MMOL/L. THE RESULT OF 119 MMOL/L WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. IT IS UNKNOWN IF THE FIRST SAMPLE WAS TESTED AND REPEATED IN THE PRIMARY TUBE. CLARIFICATION WAS REQUESTED BUT NOT PROVIDED. THE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15740518 ↗
• MalfunctionSep 12, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER INITIALLY COMPLAINED ABOUT THIRD PARTY QC RESULTS FOR CHLORIDE (CL) AFTER CHANGING THE ELECTRODE ON A COBAS 6000 C (501) MODULE. CL ELECTRODE LOT # V0204 HAD BEEN INSTALLED ON (B)(6) 2018 AND THE CUSTOMER HAD NO QC ISSUES WITH THIS ELECTRODE. ON (B)(6) 2018 NEW CL ELECTRODE WITH LOT # W9817 WAS INSTALLED. THE REFERENCE ELECTRODE HAD LAST BEEN REPLACED IN (B)(6) 2018. UPON REPLACING THE CL ELECTRODE, QC RESULTS SHIFTED HIGH. ON (B)(6) 2018 THE CUSTOMER ALSO QUESTIONED RESULTS FOR PATIENTS TESTED FOR CL. AN ISE CHECK PASSED ON THE DAY OF THE EVENT. WHEN THE ISE'S WERE CALIBRATED, A CALIBRATION FLAG WAS GENERATED FOR CL AND THE VALUE WAS [-] 10. THE TECH DIDN'T REALIZE THIS AND RAN PATIENT SAMPLES. ONCE THE CL RESULTS BEGAN TO SHOW FLAGS FOR DELTA CHECKS, THE TECH STOPPED RUNNING PATIENT SAMPLES. THE TECH RE-CALIBRATED AND REPEATED PATIENT SAMPLES. THE CUSTOMER PROVIDED DATA FOR 1 PATIENT SAMPLE AND THE CL RESULTS WERE DISCREPANT. THE ORIGINAL CL RESULT WAS 98 MMOL/L. THE REPEAT RESULT WAS 97.6 MMOL/L. AFTER THE TECH RE-CALIBRATED THE CL RESULT WAS 109 MMOL/L. THE ORIGINAL RESULT HAD BEEN REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS AFTER RE-CALIBRATION WERE BEL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7868054 ↗

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.