Sodium electrode 10825468001 (UDI 08430215011546)Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 08430215011546), received between Jul 13, 2018 and Nov 26, 2024 — classified as 99 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (42 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH SODIUM RESULTS FROM THE COBAS PURE C 303 ANALYTICAL UNIT COMPARED TO A COBAS B221 ANALYZER. THE RESULT FROM THE COBAS B221 WAS 141 MMOL/L. THE RESULT FROM THE COBAS C303 ANALYZER WAS 149 MMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784538 ↗
• MalfunctionNov 12, 2024High Test Results; Low Readings; High Test Results; Low Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE NA ELECTRODE RESULTS FOR 37 PATIENT SAMPLES ON A COBAS PRO ISE ANALYTICAL UNIT. PLEASE REFER TO THE ATTACHMENT "(B)(6)" FOR EXAMPLES OF QUESTIONABLE PATIENT RESULTS. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND CORRECTED REPORTS WERE SENT. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER MODULE AND WERE BELIEVED TO BE CORRECT. THE SAMPLES WERE REPEATED DUE TO FAILED QUALITY CONTROLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20666805 ↗
• MalfunctionNov 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 1 PATIENT PLASMA SAMPLE TESTED ON A COBAS 6000 C (501) MODULE. RESULTS FOR THE SODIUM (NA) TESTS WERE AFFECTED. INITIAL RESULT: 131 MMOL/L. REPEAT RESULT: 137 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20654131 ↗
• MalfunctionOct 29, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE HIGH RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH THE NA ELECTRODE ON A COBAS 6000 C (501) MODULE. THE CUSTOMER TRIED RE-CALIBRATING AND RAN CONTROLS. THE CALIBRATION FAILED. THE CUSTOMER THEN REPLACED THE ELECTRODES AND REAGENT. CALIBRATION PERFORMED ON THE STANDBY REAGENTS WAS SUCCESSFUL, BUT THE CALIBRATION WITH THE IN-USE REAGENT FAILED. CONTROLS FAILED ON BOTH STANDBY AND IN-USE REAGENTS. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT SAMPLE THAT HAD DISCREPANT NA RESULTS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A NA VALUE OF 171 MMOL/L. THE CUSTOMER DECIDED TO REPEAT THE SAMPLE SINCE THE INITIAL VALUE WAS HIGH. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 137 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561642 ↗
• MalfunctionOct 3, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE COBAS 6000 C 501 ANALYZER. THE INITIAL RESULT WAS 163 MMOL/L AND THE REPEAT RESULT WAS 139 MMOL/L. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362860 ↗
• MalfunctionSep 19, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE NA ELECTRODE RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 C (501) MODULE. PATIENT 1: (ID: (B)(6): THE INITIAL RESULT WAS 177 MMOL/L. THE REPEATED RESULT WAS 135 MMOL/L. PATIENT 2: (ID: (B)(6): THE INITIAL RESULT WAS 167 MMOL/L. THE REPEATED RESULT WAS 138 MMOL/L. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND CORRECTED REPORTS WERE FILED. THE SAMPLES WERE REPEATED DUE TO FAILING DELTA CHECKS AND THE INITIAL RESULT FOR PATIENT 1 DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER ANALYZER AND WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260712 ↗
• MalfunctionSep 9, 2024Low Test Results; Low Test Results

  THE CUSTOMER STATED THEY RECEIVED QUESTIONABLE ISE RESULTS FOR APPROXIMATELY 19 PATIENT SAMPLES TESTED ON A COBAS 8000 ISE MODULE. THE SAMPLES WERE REPEATED AND 11 SAMPLE RESULTS NEEDED CORRECTION. THE CUSTOMER NOTED THEY REPLACED THE ISE ELECTRODES AND AFTER THIS, ALL CONTROLS WERE OUTSIDE OF RANGE. ISE CHECKS WERE ALSO FAILING. THE CUSTOMER TRIED RUNNING CLEANING MAINTENANCE, CONDITIONING THE ELECTRODES, REPLACING SYSTEM REAGENTS, AND REPLACING THE PINCH VALVE TUBING. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT NA ELECTRODE RESULTS. THE SAMPLE INITIALLY RESULTED IN A NA VALUE OF 133 MMOL/L. CONTROLS TESTED AFTER THE PATIENT SAMPLE RUN WERE OUTSIDE OF RANGE, SO THIS PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED, RESULTING IN A NA VALUE OF 141 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171310 ↗
• MalfunctionSep 6, 2024High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 5 PATIENT SAMPLES TESTED ON A COBAS PRO ISE ANALYTICAL UNIT. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE TESTED FOR CL ELECTRODE (CL) AND NA ELECTRODE (NA). THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE DOCTOR QUESTIONED THEM. THE SAMPLES WERE REPEATED ON A DIFFERENT ISE ANALYZER. THE INITIAL NA RESULT WAS 154.9 MMOL/L. THE REPEAT RESULT WAS 140.1 MMOL/L. THE INITIAL CL RESULT WAS 116.9 MMOL/L. THE REPEAT RESULT WAS 104.1 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157924 ↗
• MalfunctionSep 3, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS 6000 C 501 MODULE. THE CUSTOMER CHANGED THE ELECTRODES AND REPEATED THE SAMPLES. THE INITIAL SODIUM RESULT WAS 120 MMOL/L AND THE REPEAT RESULT WAS 141 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 20126828 ↗
• MalfunctionAug 22, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT TESTED FOR NA ELECTRODE (NA) ON A COBAS 6000 C (501) MODULE. THE INITIAL RESULT WAS 177 MMOL/L. THE REPEAT RESULT WAS 143 MMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031350 ↗
• MalfunctionJul 25, 2024Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS 8000 COBAS ISE MODULE WHEN COMPARED TO A DIFFERENT COBAS ISE MODULE. RESULTS FOR THE FOLLOWING TESTS WERE AFFECTED: SODIUM (NA), POTASSIUM (K), AND CHLORIDE (CL). NA: INITIAL RESULT: 192 MMOL/L. REPEAT RESULT: 139 MMOL/L (TESTED ON ANOTHER ISE). K: INITIAL RESULT: 6.3 MMOL/L. REPEAT RESULT: 4.4 MMOL/L (TESTED ON ANOTHER ISE). CL: INITIAL RESULT: 66 MMOL/L. REPEAT RESULT: 106 MMOL/L (TESTED ON ANOTHER ISE). THE CUSTOMER QUESTIONED THE INITIAL RESULTS AND REPEATED THE SAMPLE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829672 ↗
• MalfunctionJul 25, 2024High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR NA ELECTRODE (NA) ON A COBAS 6000 C (501) MODULE. THE INITIAL RESULT WAS 162 MMOL/L. SINCE THIS RESULT WAS HIGHER THAN EXPECTED, THE SAMPLE WAS REPEATED WITH A RESULT OF 131 MMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19828961 ↗
• 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 NA REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CL 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 19773117 ↗
• MalfunctionJul 16, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 4 PATIENT SAMPLES ON A COBAS 6000 C (501) MODULE. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLES AS QC PERFORMED AFTER THE INITIAL PATIENT SAMPLE RUN WAS OUT OF THE ACCEPTABLE RANGE. FOR SAMPLE 1, THE INITIAL RESULT WAS 132 MMOL/L. THE REPEAT RESULT WAS 138 MMOL/L. FOR SAMPLE 2, THE INITIAL RESULT WAS 132 MMOL/L. THE REPEAT RESULT WAS 139 MMOL/L. FOR SAMPLE 3, THE INITIAL RESULT WAS 131 MMOL/L. THE REPEAT RESULT WAS 138 MMOL/L. FOR SAMPLE 4, THE INITIAL RESULT WAS 131 MMOL/L. THE REPEAT RESULT WAS 137 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT. THE CUSTOMER ALSO REPEATED THE SAMPLES ON ANOTHER ANALYZER AND THE RESULTS MATCHED THE REPEAT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749838 ↗
• MalfunctionJul 16, 2024Low Test Results; Insufficient Device Problem Information; Non Reproducible Results; Low Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ISE INDIRECT NA FOR GEN.2 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO ISE ANALYTICAL UNIT THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULT FROM A SECOND PATIENT SAMPLE WAS DIFFERENT PROMPTING THE RERUN OF THE INITIAL PATIENT SAMPLE. THE INITIAL NA RESULT WAS 112.9 MMOL/L. THE REPEAT RESULT WAS 135.3 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749175 ↗
• MalfunctionJul 15, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS 6000 C501 ANALYZER. RESULTS FOR THE SODIUM (NA) TEST WERE AFFECTED. INITIAL RESULT: 150 MMOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS AND REPEATED THE SAMPLE. REPEAT RESULT: 143 MMOL/L. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19741354 ↗
• MalfunctionJul 3, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE NA ELECTRODE ON A COBAS PRO ISE ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN A NA VALUE OF 115 MMOL/L. THE PHYSICIAN QUESTIONED THE VALUE THE SAMPLE WAS REPEATED TWICE ON A SECOND ANALYZER, RESULTING IN NA VALUES OF 122 MMOL/L AND 124 MMOL/L. THE 124 MMOL/L VALUE WAS DEEMED CORRECT AND AN AMENDED REPORT WAS ISSUED. THE SECOND SAMPLE INITIALLY RESULTED IN A NA VALUE OF 114 MMOL/L. THE PHYSICIAN QUESTIONED THE VALUE. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 120 MMOL/L. THE 120 MMOL/L VALUE WAS DEEMED CORRECT AND AN AMENDED REPORT WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19670010 ↗
• 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 NA ELECTRODE. REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE CL 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 PT (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 NA ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE K ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE CL ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (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 VALU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511493 ↗
• MalfunctionMay 24, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA AND K FOR GEN.2 RESULTS FROM MULTIPLE SAMPLES TESTED ON THE COBAS 6000 C 501 (UL) V. THE REPORTER STATED THAT SOME QUESTIONABLE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND THE LOW ANION GAPS PROMPTED THE RERUN OF PATIENT SAMPLES. THE REPORTER WAS ABLE TO PROVIDE TWO PATIENT SAMPLES WITH DISCREPANT RESULTS: SAMPLE ID 0423:C02503S: THE INITIAL NA RESULT WAS 120 MMOL/L. THE REPEAT RESULT WAS 139 MMOL/L. SAMPLE ID 0423:C02514S: THE INITIAL NA RESULT WAS 127 MMOL/L. THE REPEAT RESULT WAS 138 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393129 ↗
• MalfunctionMay 23, 2024Incorrect, 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 SODIUM RESULTS FROM THE COBAS PRO ISE ANALYTICAL UNIT. SAMPLE 111761155 INITIAL RESULT WAS 149 MMOL/L AND THE REPEAT RESULT WAS 140 MMOL/L. SAMPLE 111761293 INITIAL RESULT WAS 140 MMOL/L AND THE REPEAT RESULT WAS 134 MMOL/L. SAMPLE 111761354 INITIAL RESULT WAS 138 MMOL/L AND THE REPEAT RESULT WAS 132 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381041 ↗
• MalfunctionMay 14, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE NA ELECTRODE ON A COBAS 6000 C (501) MODULE. THE INITIAL VALUES WERE QUESTIONED BY A PHYSICIAN, SO THE SAMPLES WERE REPEATED. THE REPEAT RESULTS WERE DEEMED CORRECT. THE FIRST SAMPLE INITIALLY RESULTED IN A NA VALUE OF 120 MMOL/L AND IT WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 129 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A NA VALUE OF 123 MMOL/L AND IT WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 137 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19314371 ↗
• MalfunctionMay 7, 2024Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 1 PATIENT PLASMA SAMPLE TESTED ON A COBAS PRO ISE ANALYTICAL UNIT COMPARED TO A DIFFERENT COBAS PRO ISE ANALYTICAL UNIT. RESULTS FOR THE SODIUM (NA) TEST WERE AFFECTED. INITIAL RESULT: 150 MMOL/L. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMP,E WAS REPEATED. REPEAT RESULT: 142 MMOL/L (TESTED ON ANOTHER COBAS PRO ISE). THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260757 ↗
• MalfunctionApr 19, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE NA ELECTRODE RESULTS FOR 10 PATIENT SAMPLES ON A COBAS 6000 C (501) MODULE. REFER TO THE ATTACHMENT "(B)(6) " FOR PATIENT RESULTS. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED DUE TO THE DOCTOR NOTICING ONE OF THE RESULTS DID NOT MATCH THE PATIENT'S HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143627 ↗
• MalfunctionApr 16, 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 SODIUM RESULTS FROM THE COBAS 6000 C 501 ANALYZER. SAMPLE (B)(6) INITIAL RESULT WAS 130 MMOL/L AND A REPEAT RESULT WAS 139 MMOL/L FROM THE SAME AND FROM ANOTHER COBAS C501. SAMPLE (B)(6) INITIAL RESULT WAS 144 MMOL/L AND THE REPEAT RESULT WAS 151 MMOL/L FROM THE SAME AND FROM ANOTHER COBAS C501. SAMPLE (B)(6) INITIAL RESULT WAS 129 MMOL/L AND THE REPEAT RESULT WAS 135 MMOL/L FROM THE SAME ANALYZER AND 134 FROM ANOTHER COBAS C501. SAMPLE (B)(6) INITIAL RESULT WAS 124 MMOL/L AND THE REPEAT RESULT WAS 131 MMOL/L FROM THE SAME ANALYZER AND 129 FROM ANOTHER COBAS C501. THE REPEAT RESULTS WERE BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119355 ↗
• MalfunctionApr 16, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE COBAS 6000 C 501 ANALYZER. THE SAMPLES WERE REPEATED ON A COBAS PURE C303 ANALYZER. PATIENT 1 INITIAL RESULT WAS 130 MMOL/L AND THE REPEAT RESULT WAS 141 MMOL/L. ON (B)(6) 2024, PATIENT 2 INITIAL RESULT WAS 129 MMOL/L AND THE REPEAT RESULT WAS 135 MMOL/L. ON (B)(6) 2024, PATIENT 3 INITIAL RESULT WAS 132 MMOL/L AND THE REPEAT RESULT WAS 139 MMOL/L. THE REPEAT RESULTS WERE BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19117787 ↗

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.