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cobas c 311 4826876001Recalls & reported problems

Roche Diagnostics GmbH · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Roche cobas c 311 lab analyzer has 202 adverse event reports, with no injuries and no deaths. Many describe test results that could not be repeated or came out too high or too low, such as sodium results that were rerun and differed. 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
203
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 203 adverse event reports that list this exact device (DI 04015630925551), received between Jul 26, 2018 and Sep 10, 2026 — classified as 203 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (101 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 5 reportsJan 2024: 3 reportsFeb 2024: 4 reportsMar 2024: 2 reportsApr 2024: 2 reportsMay 2024: 4 reportsJun 2024: 3 reportsJul 2024: 8 reportsAug 2024: 2 reportsSep 2024: 5 reportsOct 2024: 3 reportsNov 2024: 2 reportsDec 2024: 4 reportsJan 2025: 3 reportsFeb 2025: 6 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 2 reportsJun 2025: 3 reportsJul 2025: 8 reportsAug 2025: 2 reportsSep 2025: 3 reportsOct 2025: 1 reportsNov 2025: 6 reportsDec 2025: 3 reportsJan 2026: 3 reportsFeb 2026: 1 reportsMar 2026: 6 reportsApr 2026: 5 reportsMay 2026: 2 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520268
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Non Reproducible Results101
  • High Test Results65
  • Low Test Results48
  • Incorrect, Inadequate or Imprecise Result or Readings38
  • Incorrect Measurement7
  • Output Problem3
  • Low Readings2
  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • No Clinical Signs, Symptoms or Conditions179
  • No Consequences Or Impact To Patient17
  • No Known Impact Or Consequence To Patient7

Recent adverse event reports

The 25 most recent of 203 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 10, 2026High Test Results

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50717076 ↗
  • MalfunctionSep 8, 2026Non Reproducible Results

    There was an allegation of questionable Tina-quant Hemoglobin A1c Gen.3 - Hemolysate and Whole Blood Application results from the Cobas 4000 c311 stand alone system.Sample 1 initial result was (b)(6), and the repeat result was (b)(6).Sample 2 initial result was (b)(6), and the repeat result was (b)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50668279 ↗
  • MalfunctionAug 27, 2026High Test Results

    There was an allegation of questionable Magnesium Gen.2 results for 1 patient sample on a Cobas 4000 c311 stand alone system.The initial result was 3.06 mg/dL with flag.The repeat result was 1.69 mg/dL.The repeat result was deemed correct.No questionable results were reported outside of the laboratory.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50480768 ↗
  • MalfunctionMay 29, 2026Low Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FROM THE COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL RESULT WAS 47.3 MG/DL, AND THE REPEAT RESULT WAS 71.8 MG/DL. 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 25334198 ↗
  • MalfunctionMay 4, 2026Non Reproducible Results

    WE RECEIVED AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENTS' SAMPLES TESTED ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE CLINICIANS QUESTIONED THE INITIAL RESULTS FROM THE ANALYZER, PROMPTING THE RERUN OF THE SAMPLES AT A DIFFERENT LABORATORY USING A DIFFERENT C311 SYSTEM. THE CUSTOMER ALLEGED THAT THE REPEAT RESULTS WERE APPROXIMATELY 7 MMOL/L LOWER AND WERE MORE ALIGNED WITH THE EXPECTED RESULTS. DISCREPANCY RESULTS FOR 1 PATIENT SAMPLE WERE PROVIDED: INITIAL RESULT: 148 MMOL/L. REPEAT RESULT: 141 MMOL/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25067052 ↗
  • MalfunctionApr 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE AND BICARBONATE ASSAY RESULTS WITH SEVERAL PATIENT SAMPLES TESTED ON THE COBAS 4000 C311 STAND ALONE SYSTEM. SAMPLE 1: THE INITIAL SODIUM RESULT WAS 150 MMOL/L. THE REPEAT SODUM RESULT WAS 136 MMOL/L. SAMPLE 2: THE INITIAL SODIUM RESULT WAS 216 MMOL/L. THE REPEAT SODUM RESULT WAS 140 MMOL/L. SAMPLE 3: THE INITIAL BICARBONATE RESULT WAS 50 MMOL/L. THE REPEAT BICARBONATE RESULT WAS 23.2 MMOL/L. THE FIELD SERVICE ENGINEER (FSE) CLEANED THE CUVETTES, FIXED A DAMAGED VACUUM TUBE, AND PERFORMED QC AND CALIBRATION SUCCESSFULLY. HOWEVER, ADDITIONAL QUESTIONABLE RESULTS WERE GENERATED. SAMPLE 4: THE INITIAL SODIUM RESULT WAS 158 MMOL/L. THE REPEAT SODUM RESULT WAS 139 MMOL/L. SAMPLE 5: THE INITIAL SODIUM RESULT WAS 128 MMOL/L. THE REPEAT SODUM RESULT WAS 139 MMOL/L. SAMPLE 6: THE INITIAL SODIUM RESULT WAS 128 MMOL/L. THE REPEAT SODUM RESULT WAS 142 MMOL/L. SAMPLE 7: THE INITIAL SODIUM RESULT WAS 123 MMOL/L. THE REPEAT SODUM RESULT WAS 141 MMOL/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25047436 ↗
  • MalfunctionApr 29, 2026High Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION ASSAY RESULTS FOR 3 PATIENT SAMPLES TESTED ON THE COBAS 4000 C311 STAND ALONE SYSTEM. SAMPLE1: THE INITIAL RESULT WAS 11%. THE REPEAT RESULT WAS 9.3% AT ANOTHER LAB. PATIENT 2: THE INITIAL RESULT WAS 10.2%. THE REPEAT RESULT WAS 8.6% AT ANOTHER LAB. PATIENT 3: THE INITIAL RESULT WAS 5.7%. THE REPEAT RESULT WAS 5.0% AT ANOTHER LAB. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25030952 ↗
  • MalfunctionApr 29, 2026Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE AND CHLORIDE ELECTRODE RESULTS FROM THE COBAS 4000 C311 STAND ALONE SYSTEM FOR THREE PATIENTS. PATIENT 1'S INITIAL SODIUM RESULT WITH A PLASMA SAMPLE WAS 117 MMOL/L, AND THE REPEAT RESULT WAS 132 MMOL/L. PATIENT 2'S INITIAL SODIUM RESULT WITH A SERUM SAMPLE WAS 290 MMOL/L, AND THE REPEAT RESULT WAS 134 MMOL/L. THE INITIAL CHLORIDE RESULT WAS 124.5 MMOL/L, AND THE REPEAT RESULT WAS 102.2 MMOL/L. PATIENT 3'S INITIAL SODIUM RESULT ON (B)(6) 2026 WITH A PLASMA SAMPLE WAS 198 MMOL/L, AND THE REPEAT RESULT WAS 131 MMOL/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25027973 ↗
  • MalfunctionApr 3, 2026Non Reproducible Results

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CREATININE PLUS VER.2 (CREP2) ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL RESULT WAS 1.58 MG/DL. ON (B)(6) 2026, THE REPEAT RESULT WAS 0.84 MG/DL. ON (B)(6) 2026, A NEW SAMPLE WAS OBTAINED, AND THE RESULT WAS 0.88 MG/DL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24779464 ↗
  • MalfunctionApr 2, 2026High Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL RESULT WAS 14.47 MG/DL, AND THE REPEATED RESULT WAS 9.76 MG/DL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24764373 ↗
  • MalfunctionMar 30, 2026High Test Results

    THERE WAS AN ALLEGATION OF A QUESTIONABLE CALCIUM GEN.2 RESULT FOR A PATIENT SAMPLE TESTED ON THE COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL RESULT WAS 10.2 MG/DL. THE REPEAT RESULT WAS 7.3 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24718514 ↗
  • MalfunctionMar 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH TRIGLYCERIDES ASSAY ON A COBAS 4000 C311 STAND ALONE SYSTEM. PATIENT 1: INITIAL RESULT: 700 MG/DL. REPEAT RESULT: 100 MG/DL. PATIENT 2: INITIAL RESULT: 100 MG/DL A NEW SAMPLE WAS DRAWN AND TESTED, RESULTING IN A TRIGLYCERIDES VALUE OF 200 MG/DL. THE CUSTOMER PERFORMED REPEATABILITY TESTS USING DIFFERENT CONTROL MATERIALS AND NOTED THAT WHILE 20 REPETITION TIMES OBTAINED SIMILAR RESULTS, THE REPETITION FOR THE 21ST TIME OBTAINED A VERY HIGH VALUE. NO EXACT VALUES WERE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24714610 ↗
  • MalfunctionMar 16, 2026High Test Results

    WE RECEIVED AN ALLEGATION OF A QUESTIONABLE HIGH POTASSIUM ELECTRODE RESULT FOR 1 PATIENT SAMPLE TESTED ON A COBAS 4000 C311 STAND ALONE SYSTEM. INITIAL RESULT: 4.06 MMOL/L. REPLACING THE ELECTRODES BY THE CUSTOMER PROMPTED THE REPEAT OF THE SAMPLE. REPEAT RESULT: 4.56 MMOL/L. THE INITIAL RESULT WAS DEEMED TO BE CORRECT AS IT MATCHED THE PATIENT'S PREVIOUS RESULTS. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24611541 ↗
  • MalfunctionMar 11, 2026Low Test Results

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 1 PATIENT SAMPLE TESTED FOR SODIUM ELECTRODE (NA) AND POTASSIUM ELECTRODE (K) ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE PATIENT SAMPLE INITIALLY RESULTED IN THE FOLLOWING VALUES: SODIUM = 89 MMOL/L. POTASSIUM = 3.06 MMOL/L. THE INITIAL RESULTS WERE QUESTIONED DUE TO LOW VALUES AND A REPEAT TEST WAS RUN. THE SAMPLE WAS REPEATED RESULTING IN THE FOLLOWING VALUES: SODIUM = 140 MMOL/L. POTASSIUM = 4.74 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT, AS THEY WERE WITHIN THE NORMAL VALUES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24575256 ↗
  • MalfunctionMar 9, 2026High Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE HEMOGLOBIN A1C RESULTS USING HEMOLYZING REAGENT (FOR WHOLE BLOOD AND HEMOLYSATE HBA1C) REAGENT ON THE COBAS 4000 C311 STAND ALONE SYSTEM. PATIENT 1 INITIAL RESULT WAS 9.2%, AND THE REPEAT RESULT WAS 5.9 %. PATIENT 2 INITIAL RESULT WAS 10.7%, AND THE REPEAT RESULT WAS 6.7%.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24544774 ↗
  • MalfunctionMar 2, 2026Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL RESULT WAS 166 MMOL/L, AND THE REPEATED RESULT WAS 173 MMOL/L. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT BECAUSE IT WAS OBTAINED USING NEW ELECTRODES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24488231 ↗
  • MalfunctionFeb 2, 2026Non Reproducible Results

    WE RECEIVED AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED ON A COBAS 4000 C311 STAND ALONE SYSTEM. ONE EXAMPLE OF DISCREPANT RESULTS FOR ONE PATIENT SAMPLE WAS PROVIDED: ON (B)(6) 2026, THE INITIAL RESULT WAS 174 MMOL/L. THE INITIAL RESULT WAS NOT REPORTED BECAUSE IT WAS ELEVATED AND DID NOT MATCH THE EXPECTED VALUES, PROMPTING A RERUN. ON (B)(6) 2026, THE REPEAT RESULT: 142 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT, AS IT WAS WITHIN THE NORMAL VALUES AND WAS REPORTED OUTSIDE THE LABORATORY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24233387 ↗
  • MalfunctionJan 22, 2026High Test Results; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL SODIUM RESULT WAS 155 MMOL/L, AND THE REPEAT RESULTS WERE 140 MMOL/L AND 140 MMOL/L. THE INITIAL POTASSIUM RESULT WAS 5.65 MMOL/L, AND THE REPEAT RESULTS WERE 4.79 MMOL/L AND 4.84 MMOL/L. THE INITIAL CHLORIDE RESULT WAS 114 MMOL/L, AND THE REPEAT RESULTS WERE 103 MMOL/L AND 102.6 MMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24152867 ↗
  • MalfunctionJan 19, 2026Low Test Results; Non Reproducible Results

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 4.8 %. WHEN TESTED ON AN UNKNOWN POINT OF CARE DEVICE, THE RESULT WAS 5.3 %.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24108375 ↗
  • MalfunctionJan 6, 2026Decrease in Suction; Obstruction of Flow; Low Test Results; No Flow; Suction Failure

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM (NA) AND POTASSIUM (K) RESULTS FOR 3 PATIENT SAMPLES ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE CUSTOMER WAS PROMPTED TO REPEAT THE PATIENT SAMPLES BECAUSE THE CLINICAL STAFF QUESTIONED THE RESULTS AS THEY DID NOT MATCH THE BLOOD GAS RESULTS. FOR SAMPLE 1, THE INITIAL NA RESULT WAS 128 MMOL/L AND THE INITIAL K RESULT WAS 3.72 MMOL/L. THE REPEAT NA RESULT WAS 141 MMOL/L AND THE REPEAT K RESULT WAS 4.04 MMOL/L. FOR SAMPLE 2, THE INITIAL NA RESULT WAS 130 MMOL/L AND THE INITIAL K RESULT WAS 3.52 MMOL/L. THE REPEAT NA RESULT WAS 142 MMOL/L AND THE REPEAT K RESULT WAS 3.82 MMOL/L. FOR SAMPLE 3, THE INITIAL NA RESULT WAS 132 MMOL/L AND THE INITIAL K RESULT WAS 3.82 MMOL/L. THE REPEAT NA RESULT WAS 145 MMOL/L AND THE REPEAT K RESULT WAS 4.15 MMOL/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23979526 ↗
  • MalfunctionDec 17, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT C-REACTIVE PROTEIN IV RESULTS FROM THE COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL RESULT WAS <0.6 MG/L. THE CLINICIANS QUERIED THE INITIAL LOW RESULT AS IT DID NOT CORRELATE WITH THE PATIENT¿S CLINICAL PRESENTATION OR THE PREVIOUS DAY'S HIGH CRP RESULT. THE REPEAT RESULT WAS 123.6 MG/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23827640 ↗
  • MalfunctionDec 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE AND ISE INDIRECT NA-K-CL FOR GEN.2 RESULTS FOR 5 PATIENT SAMPLES ON A COBAS 4000 C311 STAND ALONE SYSTEM. SAMPLE 1 HAD AN INITIAL NA RESULT OF 122 MMOL/L WITH A DATA FLAG, AN INITIAL K RESULT OF 4.15 MMOL/L, AND AN INITIAL CL RESULT OF 85.3 MMOL/L. THE REPEAT NA RESULT WAS 150 MMOL/L WITH A DATA FLAG, THE REPEAT K RESULT WAS 5.37 MMOL/L, AND THE REPEAT CL RESULT WAS 111.7 MMOL/L WITH A DATA FLAG. SAMPLE 2 HAD AN INITIAL CREATININE RESULT OF 27 UMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 80 UMOL/L. SAMPLE 3 HAD AN INITIAL NA RESULT OF 161 MMOL/L WITH A DATA FLAG, AN INITIAL K RESULT OF 6.23 MMOL/L WITH A DATA FLAG, AND AN INITIAL CL RESULT OF 129.3 MMOL/L WITH A DATA FLAG. THE REPEAT NA RESULT WAS 141 MMOL/L, THE REPEAT K RESULT WAS 4.74 MMOL/L, AND THE REPEAT CL RESULT WAS 109.9 MMOL/L WITH A DATA FLAG. SAMPLE 4 HAD AN INITIAL CREATININE RESULT OF 38 UMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 91 UMOL/L. SAMPLE 5 HAD AN INITIAL CREATININE RESULT OF 29 UMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 95 UMOL/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23816773 ↗
  • MalfunctionDec 11, 2025Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL RESULT WAS 10.07%. THE REPEAT RESULT WAS 5% ON ANOTHER PLATFORM (TOSOH G8). (B)(6) 2025: A NEW SAMPLE WAS OBTAINED AND REPEATED ON THE C311 AND THE RESULT WAS 10.08%. IT WAS INDICATED THAT THE REPEAT RESULT OF 5% WAS MORE COMPATIBLE WITH THE PATIENT'S HISTORY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23780457 ↗
  • MalfunctionNov 20, 2025Non Reproducible Results; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE CUSTOMER STATED THAT THEY HAD BEEN EXPERIENCING ABNORMAL SAMPLE ASPIRATION FOR THE PAST 15 DAYS, AS WELL AS FLUCTUATING TEST RESULTS WITHOUT ANY ALARMS. SAMPLE 1 HAD AN INITIAL RESULT OF 134.1 MG/DL. THE REPEAT RESULT WAS 87.4 MG/DL. SAMPLE 2 HAD AN INITIAL RESULT OF 130 MG/DL. THE REPEAT RESULT WAS 85 MG/DL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23606852 ↗
  • MalfunctionNov 18, 2025Non Reproducible Results; Non Reproducible Results

    THE INITIAL REPORTER RECEIVED QUESTIONABLE POTASSIUM AND CHLORIDE ELECTRODE RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 4000 C311 STAND ALONE SYSTEM. POTASSIUM THE INITIAL RESULT FROM THE ANALYZER IS 9.19 MMOL/L. THE REPEAT RESULT FROM A B 221 ANALYZER IS 4.6 MMOL/L. CHLORIDE THE INITIAL RESULT FROM THE ANALYZER IS 47.4 MMOL/L. THE REPEAT RESULT FROM A B 221 ANALYZER IS 105 MMOL/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23580726 ↗

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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