Total Protein Gen.2 08058652190Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613336121528), received between Nov 22, 2022 and Mar 17, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR TOTAL PROTEIN GEN.2 (TP2) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 3.41 G/L. THE REPEAT RESULT WAS 68.1 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619910 ↗
• MalfunctionFeb 11, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT C-REACTIVE PROTEIN IV (CRP), TOTAL PROTEIN GEN.2 (TP), AND ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP) RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER TP. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CRP RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ALP RESULTS. THE CUSTOMER WAS PROMPTED TO REPEAT THE PATIENT SAMPLES AS THEY LOOKED LIKE THEY HAD NOT BEEN CENTRIFUGED. SAMPLE 1 HAD AN INITIAL CRP RESULT OF 0.362 MG/DL AND AN INITIAL TP RESULT OF 10.6 G/DL. THE REPEAT CRP RESULT WAS 0.62 MG/DL AND THE REPEAT TP RESULT WAS 7.0 G/DL. SAMPLE 2 HAD AN INITIAL ALP RESULT OF 159 U/L. THE REPEAT RESULT WAS 88 U/L. THE REPEAT RESULTS WERE DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315633 ↗
• MalfunctionMay 14, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 703 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.119 G/DL. THE REPEATED RESULT WAS 7.81 G/DL. THE REPEATED RESULT MATCHED THE PATIENT'S CLINICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017820 ↗
• MalfunctionMar 24, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN GEN.2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 105 G/L. THE REPEAT RESULT WAS 73.5 G/L. THE REPEAT RESULT USING ANOTHER COBAS C503 ANALYZER WAS 73 G/L. THE QUESTIONABLE RESULT WAS NOT REPORTED TO THE PHYSICIAN OR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676145 ↗
• MalfunctionFeb 19, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED A STOP ERROR OCCURRED ON A COBAS C 303 ANALYTICAL UNIT. REPORTEDLY, A SPECIMEN IN PROCESS STOPPED PROCESSING AND DID NOT FINISH TESTING BUT RESULTS WERE PRODUCED AND RELEASED. THE CUSTOMER NOTED FLAGS ON MANY OF THE RESULTS AND REPEATED THE SAMPLE. AFTER REPEAT TESTING, DISCREPANT RESULTS WERE IDENTIFIED FOR TOTAL PROTEIN GEN.2 (TP2). THE INITIAL RESULT WAS 6.36 G/DL. THE REPEAT RESULT WAS 7.97 G/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410584 ↗
• MalfunctionJan 30, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TP2 TOTAL PROTEIN GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL TP2 RESULT WAS 6 G/L. THE CUSTOMER QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULT AND WAS PROMPTED TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 54 G/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606696 ↗
• MalfunctionDec 11, 2023Output Problem; Output Problem

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH TOTAL PROTEIN GEN.2 (TP2) ASSAY AND ALBUMIN BCP (ALBP) ASSAY ON A COBAS PRO C503 ANALYZER. THIS MEDWATCH WILL APPLY TO THE TP2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ALBP ASSAY. TP2: INITIAL RESULT: 5.60 G/L. REPEAT RESULT: 75.3 G/L. ALBP: INITIAL RESULT: 4.83 G/L. REPEAT RESULT: 42.4 G/L. THE MEDICAL PERSONNEL QUESTIONED THE RESULTS AND THE SAMPLE WAS THEN REPEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18305589 ↗
• MalfunctionDec 11, 2023Output Problem; Output Problem

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH TOTAL PROTEIN GEN.2 (TP2) ASSAY AND ALBUMIN BCP (ALBP) ASSAY ON A COBAS PRO C503 ANALYZER. THIS MEDWATCH WILL APPLY TO THE ALBP ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6). FOR INFORMATION RELATED TO THE TP2 ASSAY. ALBP: INITIAL RESULT: 4.83 G/L. REPEAT RESULT: 42.4 G/L. TP2: INITIAL RESULT: 5.60 G/L. REPEAT RESULT: 75.3 G/L. THE MEDICAL PERSONNEL QUESTIONED THE RESULTS AND THE SAMPLE WAS THEN REPEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18305588 ↗
• MalfunctionAug 2, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; No Apparent Adverse Event; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; No Apparent Adverse Event

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE TP2 TOTAL PROTEIN GEN.2 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT DID NOT MATCH TYPICAL RESULTS FOR THIS PATIENT AS THEY USUALLY RUN BETWEEN 6.7 AND 7.2 G/DL. THE INITIAL RESULT WAS 3.4 G/DL. THE REPORTER RERAN THE PATIENT SAMPLE 5 TIMES. THE REPEAT RESULT OF ALL 5 RERUNS WAS 6.6 G/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17444082 ↗
• MalfunctionApr 14, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 7 PATIENT'S SAMPLE TESTED WITH TP2 (TOTAL PROTEIN) ASSAY ON A COBAS PRO C503 ANALYTICAL UNIT SERIAL NUMBER (B)(4) COMPARED TO ANOTHER COBAS PRO C503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). ON (B)(6) 2023 THE CUSTOMER INITIALLY RAN THE SAMPLES ON COBAS PRO C503 ANALYTICAL UNIT SERIAL NUMBER 2176-06. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULTS. THE NEXT DAY, THE SAMPLES WERE REPEATED ON A DIFFERENT COBAS PRO C503 ANALYTICAL UNIT SERIAL NUMBER 2169-06 AND THEY GOT CORRECTED. SAMPLE 1: INITIAL RESULT: 3.5 G/DL. REPEAT RESULT: 6.84 G/DL. SAMPLE 2: INITIAL RESULT: 4.8 G/DL. REPEAT RESULT: 7.21 G/DL. SAMPLE 3: INITIAL RESULT: 3.6 G/DL. REPEAT RESULT: 7.31 G/DL. SAMPLE 4: INITIAL RESULT: 0.6 G/DL. REPEAT RESULT: 7.65 G/DL. SAMPLE 5: INITIAL RESULT: 3.6 G/DL. REPEAT RESULT: 7.3 G/DL. SAMPLE 6: INITIAL RESULT: 3.9 G/DL. REPEAT RESULT: 6.71 G/DL. SAMPLE 7: INITIAL RESULT: 0.2 G/DL. REPEAT RESULT: 7.56 G/DL. THE TP2 REAGENT LOT NUMBER WAS 693361. THE EXPIRATION DATE WAS NOT PROVIDED. QC AND CALIBRATION WERE WITHIN THE ACEPTABLE RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742920 ↗
• MalfunctionFeb 16, 2023Chemical Problem; Non Reproducible Results; Chemical Problem; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE TP2 (TOTAL PROTEIN GEN. 2) ASSAY ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A TP2 VALUE OF 0.3 G/DL, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED. THE SAMPLE WAS REPEATED RESULTING IN A VALUE OF 7.0 G/DL, WHICH WAS DEEMED CORRECT. THE TP2 REAGENT LOT WAS 63565201 WITH AN EXPIRATION DATE OF 31-JUL-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16388841 ↗
• MalfunctionJan 18, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE TP2 TOTAL PROTEIN GEN.2 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE TECHNICIAN QUESTIONED THE RESULT AFTER REPORTING IT, WHICH PROMPTED THE RERUN OF THE PATIENT SAMPLE. THE INITIAL RESULT WAS 3.2 G/DL. THE REPEAT RESULT WAS 6.4 G/DL. THE REPEAT RESULT WAS DEEMED CORRECT.  THE REAGENT LOT NUMBER IS 65383601. THE EXPIRATION DATE IS 31-OCT-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16197740 ↗
• MalfunctionNov 22, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE TOTAL PROTEIN RESULT FOR ONE PATIENT SAMPLE TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2022, THE INITIAL RESULT WAS 97.4 G/L. ON (B)(6) 2022, THE REPEAT RESULT WAS 57.3 G/L. THE REAGENT LOT NUMBER IS 59947001. THE EXPIRATION DATE IS 31-MAR-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15844240 ↗