Total Protein Urine/CSF Gen.3 08058679190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613336121535), received between Dec 2, 2022 and Mar 25, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT URINE SAMPLE TESTED FOR TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS > 2.00 G/L. THE REPEAT WITH A X20 DILUTION WAS 7.55 G/L. THE SAMPLE WAS REPEATED WITH A RESULT OF 1.49 G/L. NONE OF THE RESULTS WERE BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED AS THE RESULTS WERE INCONSISTENT WITH THE URINE ALBUMIN RESULT OF > 400 (UNIT OF MEASURE NOT PROVIDED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688297 ↗
• MalfunctionOct 24, 2024Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT URINE SAMPLE TESTED WITH CREATININE ASSAY AND TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) ASSAY ON A COBAS C503 ANALYTICAL UNIT. THE CUSTOMER ALLEGED THAT THE URINE TOTAL PROTEIN/CREATININE RATIO RESULT WAS ALSO DISCREPANT. CREATININE: INITIAL RESULT: 114.0 MG/DL. REPEAT RESULT: 5.15 MG/DL. TPUC3: INITIAL RESULT: 363 MG/DL (ACCOMPANIED BY AN INVALIDATING FLAG). THE SAMPLE WAS AUTO-REPEATED. 1ST REPEAT RESULT: 117 MG/DL (AUTO-REPEATED AND ACCOMPANIED BY AN INVALIDATING FLAG). THE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER NOTICED THE AUTO-REPEAT, QUESTIONED THE RESULT, AND REPEATED THE SAMPLE USING MANUAL DILUTION. 2ND REPEAT RESULT: 37 MG/DL (TESTED WITH MANUAL DILUTION AND REPORTED OUTSIDE THE LABORATORY). THE FINAL RESULT WAS 1845 MG/DL. THE RESULT OF 1845 MG/DL 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 20526861 ↗
• MalfunctionSep 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.63 G/L. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2024, RESULTING IN VALUES OF 0.13 G/L AND 0.11 G/L. THE CUSTOMER REPEATED THE SAMPLE BECAUSE A SECOND SAMPLE COLLECTED FROM THE PATIENT HAD VALUES SIMILAR TO THE REPEAT VALUES OBTAINED ON (B)(6) 2024. THE VALUES FROM THE SECOND SAMPLE WERE NOT PROVIDED. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY AND WAS QUESTIONED BY THE CLINICAL STAFF. DUE TO THE RESULT BEING QUESTIONED BY THE CLINICAL STAFF, THE SAMPLE WAS REPEATED. AN AMENDED REPORT WAS SENT AS THE REPEATED RESULT MATCHED THE CLINICAL PICTURE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20203024 ↗
• MalfunctionApr 8, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE TPUC3 (TOTAL PROTEIN URINE/CSF GEN.3) RESULT FROM ONE URINE PATIENT SAMPLE TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE REPORTER STATED THAT THE MICROALBUMIN RESULT OF 185 MG/L WAS INCONSISTENT WITH THE INITIAL TPUC3 RESULT PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.14 G/L. THE FIRST REPEAT RESULT WAS 0.45 G/L. THE SECOND REPEAT RESULT WAS 0.45 G/L. THE THIRD REPEAT RESULT WAS 0.45 G/L. THE FOURTH REPEAT RESULT WAS REPORTED AS 0.48 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059821 ↗
• MalfunctionJul 24, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE URINE PATIENT SAMPLE TESTED WITH TPUC3 (TOTAL PROTEIN URINE/CSF GEN.3) ON A COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(6). ON (B)(6) 2023, THE SAMPLE INITIALLY RESULTED IN A TPUC3 VALUE OF 1.40 G/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. ON (B)(6) 2023, THE SAMPLE WAS REPEATED RESULTING IN A TPUC3 VALUE OF 0.0835 G/L. THIS RESULT IS CONSISTENT WITH THE VERY LOW CONCENTRATION RESULTS OBTAINED WITH THE URINE STRIP TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375977 ↗
• MalfunctionDec 2, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE URINE PATIENT SAMPLE TESTED WITH TPUC3 (TOTAL PROTEIN URINE/CSF GEN.3) ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A TPUC3 VALUE OF 0.07 G/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE RESULT IS INCONSISTENT WITH THE MICROALBUMIN RESULT OF 273 MG/L OF THE PATIENT. THE SAMPLE WAS REPEATED ON THE NEXT DAY ON A SECOND ANALYZER RESULTING IN A TPUC3 VALUE OF 0.35 G/L. THIS RESULT IS CONSISTENT WITH THE MICROALBUMIN RESULT OF 274 MG/L OF THE PATIENT. THE TPUC3 REAGENT LOT WAS 627560 WITH AN EXPIRATION DATE OF 31-AUG-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15904113 ↗