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Sodium electrode 10825468001 (UDI 07613336227763)Recalls & reported problems

Roche Diagnostics GmbH · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This Roche sodium electrode is a lab sensor used to measure sodium in blood samples on Cobas analyzers. The 24 reports that name its identifier mostly describe incorrect high or low sodium readings that did not match the patient's history and changed when retested on another analyzer, with no deaths and no injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
26
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07613336227763), received between Apr 22, 2025 and Sep 22, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “High Test Results” (12 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 3 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 3 reportsOct 2025: 2 reportsNov 2025: 1 reportsDec 2025: 4 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 2 reportsApr 2026: 2 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 3 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • High Test Results12
  • Low Test Results10
  • Incorrect, Inadequate or Imprecise Result or Readings6
  • Non Reproducible Results6
  • Insufficient Device Problem Information4
  • Incorrect Measurement3

Patient problems

  • No Clinical Signs, Symptoms or Conditions26

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 22, 2026High Test Results

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50852947 ↗
  • MalfunctionSep 18, 2026Low Test Results

    There was an allegation of questionable ISE results from the cobas 6000 c 501 module. One example for Sodium was provided.The initial result was 116 mmol/L, and the doctor questioned the result and requested repeat testing.The repeat result using an Istat analyzer was 125 mmol/L.The repeat result was believed to be correct.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50820994 ↗
  • MalfunctionSep 2, 2026Non Reproducible Results

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50563620 ↗
  • MalfunctionAug 19, 2026High Test Results

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50327398 ↗
  • MalfunctionApr 20, 2026High Test Results; Non Reproducible Results

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE SODIUM ELECTRODE ASSAY RESULT FOR ONE PATIENT'S SAMPLE TESTED ON THE COBAS 6000 C (501) MODULE. THE INITIAL RESULT FROM THE MODULE WAS 151 MMOL/L. THE REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 139 MMOL/L. THE INITIAL RESULT DID NOT MATCH THE PATIENT'S HISTORY, PROMPTING THE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24930793 ↗
  • MalfunctionApr 13, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT SODIUM ELECTRODE RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS 6000 C (501) MODULE. A PHYSICIAN QUESTIONED THE INITIAL RESULT. THE CUSTOMER THEN RAN CONTROLS ON THE ANALYZER AND THESE WERE OUTSIDE OF RANGE LOW. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER. THE SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 128 MMOL/L AND IT REPEATED AS 134 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT AND A CORRECTED REPORT WAS ISSUED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24858022 ↗
  • MalfunctionMar 20, 2026High Test Results; Insufficient Device Problem Information

    WE RECEIVED AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 160 MMO/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT WAS HIGHER THAN THE PATIENT'S HISTORY AND MEDICAL CONDITION. THE SAMPLE WAS THEN REPEATED ON A DIFFERENT ANALYTICAL UNIT PER THE CUSTOMER'S ROUTINE PROCEDURES, AND THE REPEAT RESULT WAS 145 MMOL/L. THE LOWER RESULT WAS CONSISTENT WITH THE PATIENT'S HEALTH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24650528 ↗
  • 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 SODIUM. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE POTASSIUM 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 24629411 ↗
  • MalfunctionFeb 5, 2026Low Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FROM THE COBAS C 303 ANALYTICAL UNIT FOR TEN PATIENTS. RESULTS WERE PROVIDED FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT WAS 129.8 MMOL/L. THE REPEAT RESULT ON ANOTHER ANALYZER WAS 135 MMOL/L. PATIENT 2'S INITIAL RESULT WAS 133 MMOL/L. THE REPEAT RESULT ON ANOTHER ANALYZER WAS 140 MMOL/L. THE INITIAL RESULTS WERE QUESTIONED BY THE CUSTOMER WHEN THEY NOTICED THAT THERE WAS A DISCREPANCY IN THE SODIUM RESULTS BETWEEN THE TWO ANALYZERS. NO QUESTIONABLE RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24270474 ↗
  • 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 NA. 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 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 23987894 ↗
  • MalfunctionDec 30, 2025High Test Results; Insufficient Device Problem Information; Non Reproducible Results; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

    THE INITIAL REPORTER QUESTIONED THE RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED ON A COBAS PRO ISE ANALYTICAL UNIT. APPROXIMATELY 200 PATIENT SAMPLES WERE REPEATED, AND 70 CORRECTED REPORTS WERE ISSUED. DISCREPANT RESULTS WERE PROVIDED FOR 2 PATIENT SAMPLES TESTED FOR SODIUM ELECTRODE (NA). PATIENT 1 INITIAL RESULT WAS 140 MEQ/L. THE REPEAT RESULT WAS 132.6 MEQ/L. PATIENT 2 INITIAL RESULT WAS 141 MEQ/L. THE REPEAT RESULT WAS 134.3 MEQ/L. THE HIGH RESULTS WERE QUESTIONED, AND THE SAMPLES WERE REPEATED ON A DIFFERENT COBAS PRO ISE ANALYZER. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23920792 ↗
  • 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 SODIUM. 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 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 23830577 ↗
  • MalfunctionDec 5, 2025Low Test Results; Low Test Results

    THE INITIAL REPORTER STATED THEY HAVE BEEN HAVING ONGOING ISSUES WITH CALIBRATION FAILURES AND QUALITY CONTROL RECOVERY ON THE COBAS 8000 ISE MODULE. A PHYSICIAN QUESTIONED SODIUM ELECTRODE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT SODIUM RESULTS. THE SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 122 MMOL/L. AFTER THE PHYSICIAN QUESTIONED THE RESULT, THE SAMPLE WAS REPEATED ON AN UNKNOWN ANALYZER, RESULTING IN A VALUE OF 134 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23729128 ↗
  • MalfunctionDec 4, 2025Low Test Results; Low Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE COBAS PRO ISE ANALYTICAL UNIT. THE SAMPLES WERE REPEATED ON ANOTHER COBAS PRO ISE ANALYZER WITH RESULTS IN THE NORMAL RANGE. SAMPLE 1 INITIAL RESULT WAS 132 MMOL/L, AND THE REPEAT RESULT WAS 138.4 MMOL/L. SAMPLE 2 INITIAL RESULT WAS 133 MMOL/L, AND THE REPEAT RESULT WAS 139.3 MMOL/L. SAMPLE 3 INITIAL RESULT WAS 131 MMOL/L, AND THE REPEAT RESULT WAS 137.8 MMOL/L. SAMPLE 4 INITIAL RESULT WAS 131 MMOL/L, AND THE REPEAT RESULT WAS 137.9 MMOL/L. SAMPLE 5 INITIAL RESULT WAS 125 MMOL/L, AND THE REPEAT RESULT WAS 131.8 MMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23714997 ↗
  • MalfunctionNov 3, 2025Low Test Results; Insufficient Device Problem Information; Low Test Results; Insufficient Device Problem Information

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 ISE 1800 MODULE. THE INITIAL RESULT WAS 120.7 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULT WAS 136 MMOL/L. THIS RESULT WAS BELIEVED TO BE CORRECT. A DELTA CHECK IN THE CUSTOMER'S SYSTEM PROMPTED THE SAMPLE TO BE REPEATED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23453684 ↗
  • MalfunctionOct 29, 2025Incorrect, 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 ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL RESULT WAS 138 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULTS WERE 132 MMOL/L AND 132 MMOL/L. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL HIGH RESULT WAS QUESTIONED. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23416800 ↗
  • MalfunctionOct 21, 2025Non Reproducible Results; Non Reproducible Results

    THE INITIAL REPORTER RECEIVED QUESTIONABLE SODIUM ELECTRODE RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL NA RESULT WAS 152.7 MMOL/L. THE REPEAT RESULT WAS 143.3 MMOL/L. THE EMERGENCY DEPARTMENT (ED) PERSONNEL QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S HISTORY, PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE REPEAT RESULT WAS DEEMED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23346406 ↗
  • MalfunctionSep 18, 2025Low Test Results; Low Test Results

    THERE WAS AN ALLEGATION OF A QUESTIONABLE SODIUM ELECTRODE RESULT FROM THE COBAS 6000 C (501) MODULE FOR ONE PATIENT. THE INITIAL RESULT WAS 128 MMOL/L; THE REPEAT RESULT ON ANOTHER ANALYZER WAS 139 MMOL/L. THE INITIAL RESULT WAS REPEATED AS IT WAS QUESTIONED BY THE PHYSICIAN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23088783 ↗
  • MalfunctionSep 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

    THE INITIAL REPORTER RECEIVED QUESTIONABLE SODIUM ELECTRODE RESULTS FROM PATIENT SAMPLES TESTED ON THE COBAS 6000 C (501) MODULE. AN EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT FROM THE MODULE WAS 167 MMOL/L. THE REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 143 MMOL/L. A CRITICAL FLAG IN THE MIDDLEWARE PROMPTED THE RERUN OF THE PATIENT SAMPLE. THE REPEAT RESULT WAS DEEMED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23056420 ↗
  • MalfunctionSep 8, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

    WE RECEIVED AN ALLEGATION OF A QUESTIONABLE SODIUM ELECTRODE RESULT FOR 1 PATIENT SAMPLE TESTED ON A COBAS 6000 C 501 (UL) V MODULE. INITIAL RESULT: 175 MMOL/L. THE INITIAL RESULT DID NOT MATCH THE PATIENT'S HISTORY, PROMPTING THE REPEAT OF THE SAMPLE ON A DIFFERENT ANALYZER. REPEAT RESULT: 130 MMOL/L. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22990781 ↗
  • MalfunctionAug 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

    THERE WAS AN ALLEGATION OF ANALYZER ERRORS, QC ISSUES, AND QUESTIONABLE ISE RESULTS FROM THE COBAS 8000 COBAS ISE MODULE (DOUBLE). THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER. ONE EXAMPLE WAS PROVIDED. THE INITIAL SODIUM RESULT WAS 144 MMOL/L, AND THE REPEAT RESULT WAS 137 MMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22817664 ↗
  • MalfunctionJul 10, 2025High Test Results; High Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE ISE RESULTS FROM THE COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL SODIUM RESULT WAS 153 MMOL/L. THE REPEAT RESULT FROM ANOTHER COBAS PRO ISE ANALYTICAL UNIT WAS 145 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 22467745 ↗
  • MalfunctionMay 29, 2025Low Test Results; Low Test Results

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES TESTED WITH THE SODIUM ELECTRODE ON A COBAS 6000 C (501) MODULE. THE CUSTOMER STATED THAT CONTROLS RUN FOR SODIUM WERE OUTSIDE OF RANGE, SO THEY REPEATED PATIENT SAMPLES THAT WERE TESTED PRIOR TO THE OUTAGE. THE SAMPLES WERE REPEATED ON A SECOND ANALYZER AND OF THESE, 4 HAD DISCREPANT SODIUM RESULTS. THE REPEAT VALUES WERE DEEMED CORRECT. THE FIRST PATIENT SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 132 MMOL/L AND IT REPEATED AS 140 MMOL/L. THE SECOND PATIENT SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 130 MMOL/L AND IT REPEATED AS 136 MMOL/L. THE THIRD PATIENT SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 134 MMOL/L AND IT REPEATED AS 140 MMOL/L. THE FOURTH PATIENT SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 134 MMOL/L AND IT REPEATED AS 140 MMOL/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22104934 ↗
  • MalfunctionMay 9, 2025Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH SODIUM (NA) ON A COBAS 6000 C501 (UL) V MODULE. INITIAL RESULT: 306 MMOL/L. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY, AND THE SAMPLE WAS REPEATED ON ANOTHER C501 MODULE. REPEAT RESULT: 144 MMOL/L. THE REPEAT RESULT OF 144 MMOL/L WAS DEEMED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21993037 ↗
  • MalfunctionMay 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

    THE INITIAL REPORTER RECEIVED QUESTIONABLE NA ELECTRODE RESULTS FROM A FEW PATIENT SAMPLES TESTED ON THE COBAS 6000 C 501 (UL) V. ONE EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED: THE INITIAL NA RESULT FROM THE MODULE WAS 132 MMOL/L. THE REPEAT RESULT FROM A COBAS 8000 ANALYZER WAS 139 MMOL/L. THE DOCTOR QUESTIONED THE LOW RESULTS, PROMPTING THE RERUN OF THE PATIENT SAMPLES. THE REPEAT RESULT WAS DEEMED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21975787 ↗

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.

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