Total Protein Gen2 monocromatic 4657586190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630922833), received between Sep 6, 2024 and Sep 6, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Material Integrity Problem; Incorrect, Inadequate or Imprecise Result or Readings; Material Integrity Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH TOTAL PROTEIN 400T (TP2) ASSAY ON A COBAS C111 ANALYZER. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 5.9 MG/DL. REPEAT RESULT: 7.2 MG/DL (TESTED WITH A NEW REAGENT VIAL). THE UNIT OF MEASUREMENT OF MG/DL WAS REQUESTED TO BE VERIFIED BUT A CLARIFICATION WAS NOT RECEIVED YET. SAMPLE 2 (PATIENT 2): INITIAL RESULT: 6.0. REPEAT RESULT: 7.1 (TESTED WITH A NEW REAGENT VIAL). THE UNIT OF MEASUREMENT WAS NOT PROVIDED. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS AS THEY DID NOT MATCH THE PATIENT'S CLINICAL PICTURE AND REQUESTED THE SAMPLES TO BE REPEATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20157505 ↗
Other BIURET (COLORIMETRIC), TOTAL PROTEIN devices
- Atellica CH UCFP 11097543Siemens Healthcare Diagnostics Inc. · BIURET (COLORIMETRIC), TOTAL PROTEIN2 recalls19 reports
- ADVIA Chemistry UCFP 11319151Siemens Healthcare Diagnostics Inc. · BIURET (COLORIMETRIC), TOTAL PROTEIN2 recalls10 reports
- Atellica™ CH TP 11097604Siemens Healthcare Diagnostics Inc. · BIURET (COLORIMETRIC), TOTAL PROTEIN1 recall0 reports
- VITROS 8392292Ortho-Clinical Diagnostics, Inc. · BIURET (COLORIMETRIC), TOTAL PROTEIN1 recall0 reports
- Total Protein Gen.2 08058652190Roche Diagnostics GmbH · BIURET (COLORIMETRIC), TOTAL PROTEIN13 reports
- Total Protein Gen2 3183734190Roche Diagnostics GmbH · BIURET (COLORIMETRIC), TOTAL PROTEIN11 reports
- Total Protein Gen2 5171385190Roche Diagnostics GmbH · BIURET (COLORIMETRIC), TOTAL PROTEIN5 reports
- Atellica CH UPro 11097524Siemens Healthcare Diagnostics Inc. · BIURET (COLORIMETRIC), TOTAL PROTEIN1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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