Total Protein UrineCSF Gen3Recalls & reported problems across all models

We found 2 models of Total Protein UrineCSF Gen3 by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Jan 28, 2019 and Mar 30, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Total Protein UrineCSF Gen3 problems

Total Protein UrineCSF Gen3 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Total Protein UrineCSF Gen3 3333825190

  TURBIDIMETRIC, TOTAL PROTEIN
  19 reports
• Total Protein UrineCSF Gen3 5171954190

  TURBIDIMETRIC, TOTAL PROTEIN
  8 reports

Recent Total Protein UrineCSF Gen3 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULT FOR A URINE PATIENT SAMPLE TESTED ON THE COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL RESULT WAS 280 MG/L. THE REPEAT RESULT WAS 67 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734255 ↗
• MalfunctionNov 26, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FROM THE COBAS INTEGRA 400 PLUS ANALYZER. PATIENT 1 INITIAL RESULT WAS 275.03 MG/L, AND THE REPEAT RESULT IN ANOTHER LABORATORY WAS 82.1 MG/L. PATIENT 2 INITIAL RESULT WAS 105.5 MG/L, AND THE REPEAT RESULT IN ANOTHER LABORATORY WAS 68.1 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659510 ↗
• MalfunctionNov 25, 2025Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TOTAL PROTEIN URINE/CSF GEN.3 ASSAY ON A COBAS 8000 COBAS C 502 MODULE. INITIAL RESULT: 19.9 MG/DL. MULTIPLE CALIBRATOR FAILURES PROMPTED THE REPEAT OF THE SAMPLE ON A DIFFERENT ANALYZER. REPEAT RESULT: 8.8 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULT WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645694 ↗
• MalfunctionJul 29, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION OF A DISCREPANT RESULT FOR 1 PATIENT'S URINE SAMPLE TESTED WITH TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) ASSAY ON A COBAS 8000 C702 MODULE. ON (B)(6) 2025, THE INITIAL RESULT WAS 75 MG/L. ON (B)(6) 2025, A NEW URINE SPECIMEN WAS TAKEN FROM THE PATIENT AND TESTED ON A MINDRAY INSTRUMENT USING THE PYROGALLOL RED MOLYBDENUM METHOD IN A DIFFERENT HOSPITAL, RESULTING IN A URINE TOTAL PROTEIN VALUE OF 24 MG/L; THE ROUTINE URINE TEST WAS NEGATIVE. THE REPORTER DEEMED THE INITIAL RESULT FROM THE MODULE WAS TOO HIGH. ON (B)(6) 2025, THE REPEAT RESULT OF THE INITIAL PATIENT SAMPLE AFTER DILUTION WAS 128 MG/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY, AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE INITIAL RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650029 ↗
• MalfunctionMar 28, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULT FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 18 MG/L, THE FIRST REPEAT RESULT WAS 113 MG/L, AND THE SECOND REPEAT RESULT ON A COBAS PRO WAS 95.1 MG/L. THE SECOND AND THIRD RESULTS ARE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718322 ↗
• MalfunctionMar 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Noise, Audible; Incorrect, Inadequate or Imprecise Result or Readings; Noise, Audible

  THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 0.02 G/L AND THE REPEAT RESULT WAS 1.06 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583558 ↗
• MalfunctionJan 21, 2025High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) RESULTS FROM ONE URINE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE WAS 265 MG/DL WITH A DATA FLAG. THE FIRST REPEAT RESULT AT X2 DILUTION WAS 18 MG/DL. THE SECOND REPEAT RESULT AT X4 DILUTION WAS 6 MG/DL. THE THIRD REPEAT RESULT AT X8 DILUTION WAS UNDER 4 MG/DL. THE FOURTH REPEAT RESULT AT X10 DILUTION WAS UNDER 4 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21197175 ↗
• MalfunctionNov 6, 2024Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO 24-HOUR URINE PATIENT SAMPLES TESTED WITH TOTAL PROTEIN URINE/CSF GEN.3 ON A COBAS 8000 C 701 MODULE. THE FIRST SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 751.0 MG/L WHEN TESTED ON THE C 701 ANALYZER ON (B)(6) 2024. THE VALUE WAS NOT CONSIDERED PLAUSIBLE SINCE THE SAMPLE RESULTED IN A KAPPA FREE LIGHT CHAIN RESULT OF 5506 MG/L WHEN TESTED IN ANOTHER LABORATORY. THE SAMPLE WAS SENT TO A PARTNER LABORATORY WHERE IT WAS TESTED ON AN UNKNOWN ROCHE COBAS DEVICE, RESULTING IN A TOTAL PROTEIN VALUE OF AROUND 750 MG/L. THE SECOND SAMPLE WAS TESTED ON THE CUSTOMER'S C 701 ANALYZER ON (B)(6) 2024, RESULTING IN A TOTAL PROTEIN VALUE OF 781.1 MG/L. THE SAMPLE WAS THEN DILUTED 1:5 AND REPEATED ON THE C 701 ON (B)(6) 2024, RESULTING IN A RAW VALUE OF 65.2 MG/L. THE SAMPLE WAS ALSO DILUTED 1:10 AND REPEATED ON THE C 701 ON (B)(6) 2024, RESULTING IN A RAW VALUE OF 27.9 MG/L. THE SECOND SAMPLE WAS REPEATED ADDITIONAL TIMES ON THE CUSTOMER'S C 701 ANALYZER ON (B)(6) 2024, RESULTING IN THE FOLLOWING TOTAL PROTEIN VALUES: 748.5 MG/L WITHOUT DILUTION A RAW VALUE OF 292.8 MG/L AFTER A 1:2 DILUTION, WHICH CALCULATES TO A TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20625117 ↗
• MalfunctionSep 5, 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 TPUC3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C (501) MODULE. THE INITIAL RESULT WAS 15.2 MG/DL. THE REPEATED RESULT WAS 8.4 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER TO ENSURE THE RESULT OF 8.4 MG/DL WAS CORRECT. THE RESULT OBTAINED ON THE OTHER ANALYZER WAS NOT PROVIDED. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED DUE TO QC BEING OUT OF RANGE AFTER THE SAMPLE WAS PROCESSED. THE REPEATED RESULT OF 8.4 MG/DL WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147895 ↗
• MalfunctionAug 21, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT URINE SAMPLE TESTED WITH TOTAL PROTEIN URINE/CSF GEN. 3 ON A COBAS 8000 C702 MODULE. THE SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 3064 MG/L ACCOMPANIED BY A DATA FLAG INDICATING HIGH ABSORBANCE. THE SAMPLE WAS AUTOMATICALLY REPEATED, RESULTING IN A VALUE OF 1152 MG/L. THE SAMPLE WAS DILUTED 1:2 AND REPEATED, RESULTING IN A RAW TOTAL PROTEIN VALUE OF 1591 MG/L WHICH WAS CALCULATED TO A FINAL VALUE OF 3182 MG/L. THE SAMPLE WAS DILUTED 1:3 AND REPEATED, RESULTING IN A RAW TOTAL PROTEIN VALUE OF 931 MG/L WHICH WAS CALCULATED TO A FINAL VALUE OF 2793 MG/L. THE SAMPLE WAS DILUTED 1:5 AND REPEATED, RESULTING IN A RAW TOTAL PROTEIN VALUE OF 415 MG/L WHICH WAS CALCULATED TO A FINAL VALUE OF 2075 MG/L. THE SAMPLE WAS DILUTED 1:10 AND REPEATED, RESULTING IN A RAW TOTAL PROTEIN VALUE OF 104 MG/L WHICH WAS CALCULATED TO A FINAL VALUE OF 1040 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20009474 ↗
• MalfunctionJun 12, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TPUC3 TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FROM ONE URINE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE REPORTER WAS NOT ABLE TO PROVIDE THE DATE THE EVENT OCCURRED. THE DATE THE EVENT WAS REPORTED WAS USED AS THE DATE OF EVENT. THE PATIENT SAMPLE WAS RUN IN UNIT 1 AND UNIT 2 OF THE MODULE. THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE FROM UNIT 1 WAS 248 MG/DL. THE REPEAT RESULT WITH THE PATIENT SAMPLE AT AN UNKNOWN DILUTION FROM UNIT 1 WAS 132 MG/DL. THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE FROM UNIT 2 WAS 247 MG/DL. THE REPEAT RESULT WITH THE PATIENT SAMPLE AT AN UNKNOWN DILUTION FROM UNIT 2 WAS 141 MG/DL. THE REPORTER PERFORMED A DILUTION SERIES FOR RESULT CONFIRMATION. THE UNIT OF THE MODULE USED WAS NOT PROVIDED. THE REPEAT RESULT OF THE UNDILUTED SAMPLE WAS 259 MG/DL. THE REPEAT RESULT WITH THE PATIENT SAMPLE AT A 2-FOLD DILUTION WAS 108 MG/DL WITH A FINAL DILUTION RESULT OF 216 MG/DL. THE REPEAT RESULT WITH THE PATIENT SAMPLE AT A 4-FOLD DILUTION WAS 46 MG/DL WITH A FINAL DILUTION RESULT OF 184 MG/DL. THE REPEAT RESULT WITH THE PATIENT SAMPLE AT AN 8-FOLD DILUTION WAS 18 MG/DL WITH A FINAL DILUTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524283 ↗
• MalfunctionApr 26, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE HIGH TPUC3 TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FROM ONE URINE PATIENT SAMPLE TESTED ON THE COBAS 6000 C501 MODULE. THE INITIAL TPUC3 RESULT OF THE UNDILUTED PATIENT SAMPLE FROM THE MODULE WAS 152.6 MG/DL. THE REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:3 DILUTION FROM THE MODULE WAS 1193.4 MG/DL. THE REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE FROM THE MODULE WAS 132.6 MG/DL. THE REPEAT RESULT USING AN IMMUNOTURBIDIMETRY LABORATORY METHOD WAS 15.6 MG/L. THE REPORTER SENT THE PATIENT SAMPLE TO AN OUTSOURCED LABORATORY. THE REPEAT RESULT FROM A COMPETITOR ANALYZER USING AN IMMUNOTURBIDITY LABORATORY METHOD WAS 5.5 MG/L. THE PATIENT SAMPLE WAS ALSO SENT TO THE INVESTIGATION LABORATORY. THE REPEAT RESULT USING A BENZONTIUM CHLORIDE METHOD WAS 155.2 MG/DL. THE INVESTIGATION LABORATORY SUSPECTS THE PRESENCE OF AN INTERFERENT IN THE PATIENT SAMPLE. ADDITIONAL TPUC3 RESULTS OF 22.4 MG/DL AND 397.8 MG/DL WERE PROVIDED. IT IS NOT CLEAR HOW THESE RESULTS RELATE TO THE EVENT. CLARIFICATION HAS BEEN REQUESTED RELATED TO THESE RESULTS BUT HAS NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192430 ↗
• MalfunctionApr 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT URINE SAMPLE TESTED WITH TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) ASSAY ON A COBAS 8000 COBAS C701 MODULE WHEN COMPARED TO A NON-ROCHE ANALYZER (SIEMENS: ATHELICA SYSTEM). ON (B)(6) 2024: THE SAMPLE WAS TESTED AND THE INITIAL RESULT WAS 450 MG/DL. THE SAMPLE WAS ALSO TESTED ON SIEMENS (ATHELICA SYSTEM), RESULTING IN A TPUC3 VALUE OF 0.29 G/L. ON (B)(6) 2024 THE SAMPLE WAS REPEATED AND THE 1ST REPEAT RESULT WAS 357 MG/DL. ON (B)(6) 2024 THE SAMPLE WAS ALSO REPEATED AND THE 2ND REPEAT RESULT WAS 389 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19027099 ↗
• MalfunctionMar 1, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TPUC3 TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FOR 4 PATIENT CEREBROSPINAL FLUID SAMPLES ON A COBAS 8000 COBAS C 502 MODULE. THE CUSTOMER ALLEGED THAT THE TOTAL PROTEIN RESULTS WERE NOT PLAUSIBLE AND DID NOT MATCH WITH OTHER RESULT FINDINGS AS THE TOTAL PROTEIN CONCENTRATION WAS LOWER THAN THE ALBUMIN MEASUREMENT. ON (B)(6) 2024, SAMPLE 1 HAD A TPUC3 RESULT OF 652.1 MG/L. THE ALBUMIN RESULT WAS 814 MG/DL. THE SAMPLE WAS ALSO TESTED ON A SIEMENS ADVIA ANALYZER. THE TOTAL PROTEIN RESULT WAS 1282 MG/L AND THE ALBUMIN RESULT WAS 814 MG/DL. ON (B)(6) 2024, SAMPLE 1 WAS TESTED AGAIN AND THE TPUC3 RESULT WAS 798 MG/L AND THE ALBUMIN RESULT WAS 921 MG/L. ON (B)(6) 2024, SAMPLE 2 HAD A TPUC3 RESULT OF 257.0 MG/L. THE ALBUMIN RESULT WAS 333.0 MG/DL. ON (B)(6) 2024, SAMPLE 3 HAD A TPUC3 RESULT OF 279.7 MG/L. THE ALBUMIN RESULT WAS 361.0 MG/DL. ON (B)(6) 2024, SAMPLE 4 HAD A TPUC3 RESULT OF 403.4 MG/L. THE ALBUMIN RESULT WAS 529.0 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816883 ↗
• MalfunctionFeb 12, 2024Material Integrity Problem; Non Reproducible Results; Material Integrity Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN (TPUC3) RESULTS FOR ONE PATIENT FROM THE COBAS 8000 C702 MODULE COMPARED TO ANOTHER C702 MODULE. THE INITIAL RESULTS WERE 50.0 MG/DL AND 51.43 MG/DL. THE REPEAT RESULTS ON ANOTHER C702 MODULE WERE 33.0 MG/DL AND 33.9 MG/DL. THE REPEAT RESULTS FROM ANOTHER C702 MODULE IN ANOTHER LABORATORY WERE 48 MG/DL AND 49 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685456 ↗

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