Total Protein Gen2 3183734190Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04015630918928), received between Aug 21, 2018 and Feb 5, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (4 reports).

7 other recalls cover devices cleared under the same FDA submission (K951595); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 3 PATIENT SAMPLES TESTED FOR TOTAL PROTEIN GEN.2 (TP2) ON A COBAS 6000 C501 MODULE. OF THE DATA PROVIDED, THE RESULTS FOR 1 PATIENT SAMPLE WERE DISCREPANT. THE INITIAL RESULT WAS 7.5 G/DL. THE REPEAT RESULTS WERE 8.6 G/DL AND 8.2 G/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270486 ↗
• MalfunctionJul 31, 2025Incorrect Measurement; Incorrect Measurement

  THERE WAS AN ALLEGATION OF 12 QUESTIONABLE TOTAL PROTEIN GEN.2 RESULTS FROM THE COBAS 6000 C (501) MODULE. ONLY THE DATA FOR 1 OF THE PATIENTS WAS PROVIDED, AND IS A REPORTABLE MALFUNCTION. THE PATIENT'S INITIAL RESULT WAS 0.60 G/DL, AND THE REPEAT RESULT FROM ANOTHER INSTRUMENT WAS 6.01 G/DL. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. THE INITIAL RESULTS WERE REPEATED BECAUSE THE DOCTOR OR TECHNICIAN QUESTIONED THE CRITICAL RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676035 ↗
• MalfunctionMar 5, 2025Low Test Results; No Apparent Adverse Event; Low Test Results; No Apparent Adverse Event

  THE INITIAL REPORTER QUESTIONED RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR TOTAL PROTEIN GEN.2 (TP2) ON A COBAS 6000 C (501) MODULE. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 0.7 G/DL. THE REPEAT RESULT FROM A DIFFERENT C501 MODULE WAS 7.1 G/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526631 ↗
• MalfunctionSep 26, 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 8000 COBAS C 502 MODULE. THE INITIAL TP2 RESULT WAS 3 G/L. THE CUSTOMER QUESTIONED THE INITIAL LOW RESULT WHICH PROMPTED THEM TO REPEAT THE PATIENT SAMPLE. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 53.6 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311571 ↗
• MalfunctionSep 20, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES TESTED WITH TOTAL PROTEIN/TOTAL PROTEIN STAT ON A COBAS 6000 C501 MODULE. THE SAMPLES WERE REPEATED THE NEXT DAY AS THE LOW VALUES DID NOT MATCH THE PREVIOUS RESULTS OF THE PATIENTS. THE FIRST SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 7.21 G/DL. THE SAMPLE WAS REPEATED, RESULTING IN VALUES OF 8.65 G/DL, 8.65 G/DL, AND 8.89 G/DL. THE SECOND SAMPLE INITIALLY RESULTED IN TOTAL PROTEIN VALUES OF 3.77 G/DL WITH A DATA FLAG AND 3.85 G/DL. THE SAMPLE WAS REPEATED, RESULTING IN VALUES OF 6.49 G/DL AND 6.32 G/DL. THE THIRD SAMPLE INITIALLY RESULTED IN TOTAL PROTEIN VALUES OF 3.07 G/DL WITH A DATA FLAG, 3.07 G/DL, AND 3.13 G/DL. THE SAMPLE WAS REPEATED, RESULTING IN VALUES OF 7.37 G/DL AND 7.09 G/DL. THE FOURTH SAMPLE INITIALLY RESULTED IN TOTAL PROTEIN VALUES OF 1.78 G/DL WITH A DATA FLAG AND 1.91 G/DL. THE SAMPLE WAS REPEATED, RESULTING IN VALUES OF 6.34 G/DL, 6.57 G/DL, AND 6.40 G/DL. THE PATIENTS' RESULTS WERE AMENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267674 ↗
• MalfunctionJul 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TOTAL PROTEIN/TOTAL PROTEIN STAT ON A COBAS 6000 C 501 ANALYZER. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 2.3 G/DL. THE CUSTOMER DID NOT BELIEVE THE VALUE, SO THE SAMPLE WAS REPEATED. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 6.4 G/DL. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792013 ↗
• MalfunctionMar 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER QUESTIONED HIGH RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR TOTAL PROTEIN/TOTAL PROTEIN STAT (TP2) ON A COBAS 6000 C501 MODULE. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 5 PATIENT SAMPLES. PATIENT 1 INITIAL RESULT WAS 116 G/L. THE REPEAT RESULT WAS 74.9 G/L. THE REPEAT BY A COMPETITOR METHOD WAS 74 G/L. PATIENT 2 INITIAL RESULT WAS 101.7 G/L. THE REPEAT RESULT WAS 64.2 G/L. THE REPEAT BY A COMPETITOR METHOD WAS 63 G/L. PATIENT 3 INITIAL RESULT WAS 131 G/L. THE REPEAT RESULT WAS 76.5 G/L. THE REPEAT BY A COMPETITOR METHOD WAS 77 G/L. PATIENT 4 INITIAL RESULT WAS 138.7 G/L. THE REPEAT RESULT WAS 79.9 G/L. THE REPEAT BY A COMPETITOR METHOD WAS 80 G/L. PATIENT 5 INITIAL RESULT WAS 113.1 G/L. THE REPEAT RESULT WAS 69.1 G/L. THE REPEAT BY A COMPETITOR METHOD WAS 69 G/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED AS THE RESULTS WERE HIGHER THAN EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18939310 ↗
• MalfunctionFeb 26, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TP2 (TOTAL PROTEIN) ASSAY RESULTS FOR A PATIENT SAMPLE TESTED ON A COBAS 8000 COBAS C 502 MODULE THAT DID NOT MATCH THE RESULTS OF THE ALBUMIN AND IGGAM MEASUREMENTS OF THE SAME SAMPLE. IT WAS ALLEGED THAT THE INDIVIDUAL RESULTS OF ALBUMIN, IGM, AND IGA WOULD SUGGEST A HIGHER CONCENTRATION OF TOTAL PROTEIN IN TOTAL. THE CUSTOMER SUSPECTED AN INTERFERENCE. THE INITIAL RESULT WAS 34.6 G/L. THE REPEAT RESULT ON (B)(6) 2024 WAS 35.2 G/L AND ON (B)(6) 2024 WAS 35.7 G/L. THE TOTAL PROTEIN RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORAORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777660 ↗
• MalfunctionMar 22, 2023Low Test Results; Low Test 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 8000 COBAS C 502 MODULE, SERIAL NUMBER (B)(6). THE SAMPLE INITIALLY RESULTED IN A TP2 VALUE OF 0.02 G/DL. ON (B)(6) 2023, THE SAMPLE WAS REPEATED TWO TIMES, RESULTING IN TP2 VALUES OF 6.27 G/DL AND 6.20 G/DL. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589552 ↗
• MalfunctionDec 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ALB2 ALBUMIN GEN.2 AND TP2 TOTAL PROTEIN GEN.2 RESULTS FOR ONE PATIENT FROM DIFFERENT SAMPLES WITH COBAS 8000 C702 MODULE SERIAL NUMBERS(B)(4). THE REPORTER STATED THE PATIENT¿S ALBUMIN LEVEL HAS BEEN SLOWLY DECLINING OVER THE PAST FEW DAYS WITH TOTAL PROTEIN LEVELS INCREASING SLIGHTLY. THE CUSTOMER SUSPECTS AN INTERFERENCE AS THE RESULTS DO NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. SAMPLE (B)(6): TESTED ON SERIAL NUMBER (B)(4). THE INITIAL ALB RESULT AT 11:31 WAS 4.5 G/L. THE REPEATED RESULT AT 12:12 WAS 4 G/L. THE SECOND REPEATED RESULT AT 13:57 WAS 3.9 G/L. THE THIRD REPEATED RESULT AT 14:46 WAS 4.6 G/L. THE TP RESULT WAS 71.5 G/L. SAMPLE (B)(6): TESTED ON SERIAL NUMBER (B)(4) (INITIAL RESULT) AND (B)(4) (REPEATED RESULT) THE INITIAL ALB RESULT AT 19:54 WAS 3.4 G/L. THE REPEATED RESULT AT 22:00 WAS 4.1 G/L. THE TP RESULT WAS 73.3 G/L. SAMPLE (B)(6): TESTED ON SERIAL NUMBER (B)(4). ON (B)(6)2021, THE ALB RESULT WAS 3.7 G/L. THE TP RESULT WAS 70.8 G/L. THE QUESTIONABLE ALBUMIN RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. IT IS UNKNOWN IF THE QUESTIONABLE TOTAL PROTEIN RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13054072 ↗
• MalfunctionAug 21, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE TP2 TOTAL PROTEIN GEN.2 RESULTS FOR ONE PATIENT SAMPLE FROM COBAS 6000 C 501 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 9.0 G/DL AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WITH A 1:10 DILUTION WAS 9.8 G/DL. THE RESULT BY SHIKOKU CHUKEN METHOD WAS 7.7 G/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. AS CALIBRATION AND QC DATA WERE ACCEPTABLE, A GENERAL REAGENT OR APPLICATION COULD BE RULED OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800497 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951595. One submission often covers many models, so check the product and lot details in each record.

• Z-1675-2021 · Apr 26, 2021 · Open, Classified
  IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plas
• Z-0100-2017 · Jul 15, 2016 · Terminated
  Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone sys
• Z-0168-2014 · Sep 16, 2013 · Terminated
  COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed
• Z-0696-2013 · Nov 19, 2012 · Terminated
  Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
• Z-0012-2009 · Jun 11, 2008 · Terminated
  Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS I
• Z-0007-2009 · Jun 11, 2008 · Terminated
  Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03183696122. An in-vitro diagnostic reagent system intended for use on
• Z-0667-03 · Feb 13, 2003 · Terminated
  COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345