Total Protein Gen2 5171385190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630925100), received between Feb 7, 2023 and Mar 18, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Non Reproducible 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. SAMPLE 1: THE INITIAL RESULT WAS 0.2 G/DL, AND THE REPEATED RESULT WAS 6.8 G/DL. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL RESULT DIDN'T MATCH THE PATIENT'S CLINICAL HISTORY. SAMPLE 2: ON (B)(6) 2026, THE INITIAL RESULT WAS 0.4 G/DL, AND THE REPEATED RESULT WAS 7.5 G/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628284 ↗
• MalfunctionDec 4, 2024Output Problem; Non Reproducible Results; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE TP2 TOTAL PROTEIN GEN.2 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 5.08 G/DL. THE REPEAT RESULT WAS 7.0 G/DL..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848154 ↗
• MalfunctionSep 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TP2 TOTAL PROTEIN GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. THE INITIAL TP2 RESULT WAS 39.3 G/L. THE CUSTOMER QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS REPEATED AND THE RESULT WAS 57.3 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171086 ↗
• MalfunctionDec 4, 2023Non 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 C702 MODULE. THE INITIAL TP2 RESULT WAS 23.7 G/L. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLE AS THE RESULT DID NOT MATCH THE PATIENT'S PREVIOUS RESULT. THE SAMPLE WAS REPEATED AND THE REPEAT RESULT WAS 70.3 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256373 ↗
• MalfunctionFeb 7, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR TP2 TOTAL PROTEIN GEN.2 (TP2) ON A COBAS 8000 C 702 MODULE. THE INITIAL RESULT WAS 1.42 G/L. ON (B)(6) 2023 THE SAMPLE WAS REPEATED ON A DIFFERENT COBAS INSTRUMENT WITH A RESULT OF 65.4 G/L. THIS RESULT CORRESPONDED TO THE PATIENT¿S HEALTH. THE QUESTIONABLE LOW RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE TP2 REAGENT LOT NUMBER WAS 66367801 WITH AN EXPIRATION DATE OF 31-DEC-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16312917 ↗

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-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-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-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