cobas c 501 Module 4745914001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,628 adverse event reports that list this exact device (DI 04015630924707), received between Jul 11, 2018 and Sep 30, 2026 — classified as 5 injuries, 1,623 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (623 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 25 most recent of 1,628 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946540 ↗
• MalfunctionSep 29, 2026Incorrect Measurement; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931323 ↗
• MalfunctionSep 29, 2026High Test Results; Non Reproducible Results

  There was an allegation of questionable Urea/BUN results for 9 patient samples on a COBAS 6000 C (501) Module.Patient (b)(6):The initial result was 38 mg/dL, and the repeated result was 16 mg/dL.Patient (b)(6):The initial result was 51.0 mg/dL, and the repeated result was 20.8 mg/dL.Patient (b)(6):The initial result was 53.0 mg/dL, and the repeated result was 21.7 mg/dL.Patient (b)(6):The initial result was 86.0 mg/dL, and the repeated result was 35.2 mg/dL.Patient (b)(6):The initial result was 92.0 mg/dL, and the repeated result was 37.5 mg/dL.Patient (b)(6):The initial result was 38.0 mg/dL, and the repeated result was 15.5 mg/dL.Patient (b)(6):The initial result was 38.0 mg/dL, and the repeated result was 16.1 mg/dL.Patient (b)(6):The initial result was 63.0 mg/dL, and the repeated result was 27.7 mg/dL.Patient (b)(6):The initial result was 37.0 mg/dL, and the repeated result was 14.7 mg/dL.The repeated results were believed to be correct.The samples were repeated because of a delta check in the customer's system.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931150 ↗
• MalfunctionSep 28, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917879 ↗
• MalfunctionSep 25, 2026Non Reproducible Results

  Roche Diagnostics received a customer complaint regarding an allegedly discrepant Sodium Electrode result for a patient sample tested on a cobas c 501 Module. The initial result was 180 mmol/L. The first repeat result was 140 mmol/L. The second repeat result, tested on another device, was 135 mmol/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896644 ↗
• MalfunctionSep 25, 2026Mechanical Problem; High Test Results

  We received an allegation about discrepant Sodium Electrode results for 1 patient sample tested on a cobas 6000 c501 module.Initial result: 197 mmol/L.During the validation process, the customer noticed that the initial result was elevated, prompting a repeat of the sample.Repeat result: 138 mmol/L.The repeat result was considered correct.No questionable result was reported outside the laboratory.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896429 ↗
• MalfunctionSep 24, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885935 ↗
• MalfunctionSep 24, 2026Low Test Results

  The initial reporter received questionable Glucose HK Gen.3 assay results for two patient samples tested on the cobas 6000 c501 module.One patient sample was identified with discrepant results from the data provided:Initial analysis of the patient sample yielded 7.8 mg/dL.Repeat analysis on another c 501 module yielded 180 mg/dL.Repeat analysis on another c 501 module yielded 180 mg/dL.The initial result was not reported outside the laboratory.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882974 ↗
• MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  There was an allegation of questionable Tina-quant Albumin Gen.2 - Urine Application results for 1 patient on a cobas 6000 c501 module. The initial result was 52.5 mg/L.The repeat result was 7.7 mg/L. Additional repeat results were 31.6 mg/L and 7.5 mg/L. The results on a cobas c311 on (b)(6) 2026 were 10.8 mg/L and 5.8 mg/L. the results on the c501 on (b)(6) 2026 were 6.8 mg/L and 7.1 mg/L. A precision test was performed with the original sample, yielding the following results:25.9 mg/L,44.8 mg/L,41.0 mg/L,17.2 mg/L,13.9 mg/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870263 ↗
• MalfunctionSep 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  There was an allegation of questionable test results for 3 patient samples on a cobas 6000 c501 module. The affected assays are Uric Acid, Calcium, and Glucose. Sample 1: The initial Uric Acid result was 0.4 mg/dL, and the repeated result was 4.3 mg/dL. Sample 2: The initial Calcium result was 4 mg/dL, and the repeated result was 6 mg/dL. Sample 3: The initial Glucose result was 70 mg/dL, and the repeated result was 125 mg/dL. The samples were repeated because the initial results did not match the clinical status of the patients. The repeated results were obtained on another module and were believed to be correct.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672507 ↗
• MalfunctionSep 8, 2026High Test Results; Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668277 ↗
• MalfunctionSep 8, 2026Low Test Results

  There was an allegation of questionable Calcium Gen.2 results for 1 patient sample on a cobas 6000 c501 module.The initial result was (b)(6), and the repeated result was (b)(6).The questionable result was not reported outside the laboratory.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667219 ↗
• MalfunctionAug 28, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50501065 ↗
• MalfunctionAug 14, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50253320 ↗
• MalfunctionAug 3, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114298 ↗
• MalfunctionJun 23, 2026Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ION-SELECTIVE ELECTRODE (ISE) AND OTHER ASSAY RESULTS FROM PATIENT SAMPLES TESTED ON THE COBAS 6000 C501 MODULE. ONE EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED: SODIUM THE INITIAL RESULT WAS 254.0 MMOL/L. THE REPEAT RESULT WAS 138.0 MMOL/L. THE REPORTER DEEMED THE INITIAL RESULT UNRELIABLE, PROMPTING THE RERUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25591624 ↗
• MalfunctionJun 17, 2026Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CALCIUM GEN.2 ASSAY RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS 6000 C501 MODULE. THE REPORTER STATED THAT THE ASSAY'S INITIAL AND REPEAT PATIENT RESULTS DIFFERED BY 3 UNITS. THE FIELD SERVICE ENGINEER INSPECTED THE MODULE AND FOUND A DROPLET LEAKING FROM THE CELL RINSE UNIT. HE CLEANED THE NOZZLE AND TEFLON TIP, REPAIRED THE VACUUM CIRCUIT, AND PERFORMED A SUCCESSFUL MECHANICAL CHECK. THE EVENT WAS NOT RESOLVED, AND THE REPORTER NOTED CONSISTENTLY LOWER ASSAY PATIENT RESULTS. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25532559 ↗
• MalfunctionJun 1, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH CREATININE PLUS VER.2 ON A COBAS 6000 C501 MODULE. THE CUSTOMER INITIALLY HAD ISSUES WITH LINEARITY ALARMS FOR TWO OTHER ASSAYS RUN ON THE ANALYZER. THE CUSTOMER REPLACED THE LAMP AND PERFORMED A CELL BLANK. THE CELL BLANK WAS SUCCESSFUL. LINEARITY ALARMS RETURNED, HOWEVER, AND ON LEVEL OF CREATININE CONTROL SHIFTED LOWER. BASED ON THE CONTROL SHIFT, THE CUSTOMER REPEATED PATIENT SAMPLE TESTING FOR 240 SAMPLES. OF THESE, THREE HAD DISCREPANT CREATININE RESULTS. THE FIRST SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 55 UMOL/L. THE SAMPLE WAS REPEATED TWICE ON A SECOND ANALYZER ON (B)(6) 2026, RESULTING IN VALUES OF 91 UMOL/L AND 87 UMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 45 UMOL/L. THE SAMPLE WAS REPEATED TWICE ON A SECOND ANALYZER ON (B)(6) 2026, RESULTING IN VALUES OF 119 UMOL/L AND 118 UMOL/L. THE THIRD SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 41 UMOL/L ON (B)(6) 2026. THE SAMPLE WAS REPEATED TWICE ON A SECOND ANALYZER ON (B)(6) 2026, RESULTING IN VALUES OF 133 UMOL/L AND 134 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347326 ↗
• MalfunctionMay 27, 2026High Test Results

  THERE WAS AN ALLEGATION OF CALIBRATION AND QC ISSUES AS WELL AS QUESTIONABLE RESULTS FOR PATIENT SAMPLES FOR THE ONLINE TDM VANCOMYCIN GEN.3 ASSAY ON THE COBAS 6000 C 501 ANALYZER. ONE EXAMPLE WAS AN INITIAL RESULT OF 20.5 ¿G/ML, AND A REPEAT RESULT OF 12.6 ¿G/ML FROM ANOTHER COBAS C501 ANALYZER. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25304224 ↗
• MalfunctionMay 27, 2026Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE POTASSIUM ELECTRODE ASSAY RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS 6000 C501 MODULE. PATIENT SAMPLE 1 THE INITIAL RESULT FROM THE MODULE WAS 6.65 MMOL/L. THE REPEAT RESULT FROM ANOTHER DEVICE WAS 3.52 MMOL/L. PATIENT SAMPLE 2 THE INITIAL RESULT FROM THE MODULE WAS 7.46 MMOL/L. THE REPEAT RESULT FROM ANOTHER DEVICE WAS 3.98 MMOL/L. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AS THEY WERE DEEMED IMPLAUSIBLE, PROMPTING THE RERUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303639 ↗
• MalfunctionMay 22, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH SODIUM RESULTS FROM THE COBAS 6000 C501 MODULE. EXAMPLE 1 INITIAL RESULT WAS 174 MMOL/L, AND THE REPEAT RESULT WAS 140 MMOL/L. EXAMPLE 2 INITIAL RESULT WAS 161 MMOL/L, AND THE REPEAT RESULT WAS 138 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260087 ↗
• MalfunctionMay 21, 2026Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 C (501) MODULE. THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS WERE PROVIDED: ON 26-APR-20206: THE INITIAL RESULT FROM THE MODULE WAS 10.9%. ON 29-APR-20206: THE FIELD SERVICE ENGINEER INSPECTED THE MODULE AND FOUND THE BASIC WASH WAS OVERFLOWING INTO CELLS DUE TO DAMAGED VACUUM TUBING. HE REPLACED THIS PART, AS WELL AS THE RINSE WATER TUBING, AND ADJUSTED RINSE LEVELS TO SPECIFICATION. HE ALSO CLEANED THE PRECIPITATED BASIC WASH FROM THE TOP OF THE CELLS, THE ELECTRODES, AND THE ELECTRODE BLOCK FITTINGS. HE VERIFIED THE MODULE'S PERFORMANCE WITH MECHANISM CHECKS, CELL BLANK MEASUREMENT, ION-SELECTIVE ELECTRODE CHECKS, QCS, AND CUSTOMER-RUN PATIENT COMPARISON TESTS. THE REPEAT RESULT FROM THE MODULE AFTER SERVICE WAS 5.3%. THE REPEAT RESULT FROM ANOTHER MODULE WAS 4.8%. THE DOCTOR QUESTIONED THE INITIAL RESULT, PROMPTING THE RERUN. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25239875 ↗
• MalfunctionMay 20, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C (501) MODULE. THE INITIAL RESULT WAS 157 MMOL/L. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLE AS IT FAILED A DELTA CHECK. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 140 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232718 ↗
• MalfunctionMay 19, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2, SODIUM, AND GLUCOSE ASSAY RESULTS FOR 6 PATIENT SAMPLES ON A COBAS 6000 C501 MODULE. ON (B)(6) 2026, SAMPLE 1 HAD AN INITIAL CREATININE RESULT OF 7 MG/DL. THE REPEAT RESULT WAS 0.90 MG/DL. ON (B)(6) 2026, SAMPLE 2 HAD AN INITIAL SODIUM RESULT OF 180. THE REPEAT RESULT WAS 139. ON (B)(6) 2026, SAMPLE 3 HAD AN INITIAL GLUCOSE RESULT OF 18. THE REPEAT RESULT WAS 90. ON (B)(6) 2026, SAMPLE 4 HAD AN INITIAL CREATININE RESULT OF 7.92 MG/DL. THE REPEAT RESULT WAS 0.74 MG/DL. ON (B)(6) 2026, SAMPLE 5 HAD AN INITIAL CREATININE RESULT OF 1.62 MG/DL. THE REPEAT RESULT WAS 0.70 MG/DL. ON (B)(6) 2026, SAMPLE 6 HAD AN INITIAL SODIUM RESULT OF 186. THE REPEAT RESULT WAS 135. THE UNITS OF MEASUREMENT FOR SODIUM AND GLUCOSE WERE NOT PROVIDED. THE DATE OF EVENT WAS SET TO THE DATE THE INFORMATION WAS RECEIVED BY ROCHE; THE CUSTOMER WAS UNABLE TO PROVIDE THE EXACT DATE OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219901 ↗
• MalfunctionMay 12, 2026Off-Label Use; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE SODIUM ELECTRODE ASSAY RESULTS FOR ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 C501 MODULE. THE INITIAL RESULT IS 181 MMOL/L. THE REPEAT RESULT IS 147 MMOL/L. THE REPEAT RESULT IS 140 MMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY, AS IT WAS DEEMED HIGH AND INCOMPATIBLE WITH THE PATIENT'S CLINICAL DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25147042 ↗

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-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-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-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.