Total Protein UrineCSF Gen3 5171954190Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04015630925179), received between Oct 20, 2023 and Jul 29, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 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, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 19, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TPUC3 TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FOR 1 PATIENT URINE SAMPLE ON A COBAS 8000 COBAS C 701 MODULE. THE INITIAL URINE TPUC3 RESULT WAS 1.4 G/L. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLE AS THEY RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE REPEAT RESULT WAS 0.5 G/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18543071 ↗
• MalfunctionOct 20, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT'S URINE SAMPLE TESTED WITH TPUC3 (TOTAL PROTEIN) ON A COBAS 8000 COBAS C 701 MODULE. THE TOTAL PROTEIN RESULT WAS DEEMED IMPLAUSIBLE BASED ON THE PATIENT'S HISTORY, CONDITION, AND MEASURED MICROALBUMIN VALUE. AFTER FURTHER MEASUREMENTS, DISCREPANCIES IN RESULTS ALSO OCCURRED FOR THE ALBT2 TINA-QUANT ALBUMIN GEN.2 (MICROALBUMIN) ASSAY. THE CUSTOMER NOTED THAT THE SAMPLE APPEARED CLOUDY EVEN AFTER CENTRIFUGATION. THIS MEDWATCH WILL APPLY TO THE TOTAL PROTEIN ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE MICROALBUMIN ASSAY. THE URINE SAMPLE INITIALLY RESULTED IN THE FOLLOWING VALUES: TOTAL PROTEIN= 1620 MG/L. MICROALBUMIN = 3720 MG/L. THE SYSTEM PHOTOMETER CHECKS SHOWED A HIGH ABSORBANCE SINCE (B)(6) 2023. AN IN-HOUSE TECHNICIAN AT THE CUSTOMER SITE CHANGED THE HEAT CUT FILTER ON THE ANALYZER. THE PHOTOMETER CHECK WAS OK AFTER CHANGING THE HEAT CUT FILTER. FURTHER REPEATS OF THE SAMPLE OCCURRED ON (B)(6) 2023 AFTER THE HEAT CUT FILTER WAS CHANGED. THE CUSTOMER NOTED THE SAMPLE HAD BEEN STORED AT 4 DEGREES CELCIUS AFTER INITIAL TESTING. THE SAMPLE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17977588 ↗