Biuret (colorimetric), Total Protein
Clinical Chemistry · 21 CFR 862.1635
Recent MDR events
93 adverse event reports on file
- Atellica CHJul 31, 2026MalfunctionSiemens Healthcare Diagnostics Inc.2432235-2026-00177
- Total Protein Gen.2Jul 31, 2026MalfunctionRoche Diagnostics1823260-2026-03132
- TOTAL PROTEIN GEN.2Jul 15, 2026MalfunctionRoche Diagnostics1823260-2026-02861
- TOTAL PROTEIN GEN.2May 5, 2026MalfunctionRoche Diagnostics1823260-2026-01744
- TOTAL PROTEIN GEN.2Mar 30, 2026MalfunctionRoche Diagnostics1823260-2026-01154
- TOTAL PROTEIN GEN.2Mar 18, 2026MalfunctionRoche Diagnostics1823260-2026-00977
- TOTAL PROTEIN GEN.2Mar 17, 2026MalfunctionRoche Diagnostics1823260-2026-00950
- TOTAL PROTEIN GEN.2Feb 11, 2026MalfunctionRoche Diagnostics1823260-2026-00476
- TOTAL PROTEIN GEN.2Feb 5, 2026MalfunctionRoche Diagnostics1823260-2026-00407
- ATELLICA CHDec 19, 2025MalfunctionSiemens Healthcare Diagnostics Inc.2432235-2025-00321
Event type breakdown
Recalls
10 recall events for this product code
- Siemens Healthcare Diagnostics, Inc.Open, ClassifiedSep 8, 2025
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
Z-2542-2025 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedSep 6, 2024
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
Z-3063-2024 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedSep 6, 2024
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
Z-3064-2024 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedAug 29, 2023
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the A
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Z-1269-2023 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedNov 15, 2013
VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
Z-0322-2014 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedJun 5, 2003
Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box ide
Slides may exhibit random, elevated imprecision of results.
Z-0919-03 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedUnknown
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
Z-0180-2022 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedUnknown
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
Z-0181-2022 · View FDA record ↗ - Ortho Clinical Diagnostics IncTerminatedUnknown
VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems
Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
Z-0844-2021 · View FDA record ↗ - Ortho Clinical Diagnostics IncTerminatedUnknown
VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS
Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
Z-0845-2021 · View FDA record ↗
Registered firms
75 firms currently registered for this product code
Abaxis, Inc.
UNION CITY, CA, US
Beckman Coulter, Inc.
BREA, CA, US
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Ortho-clinical Diagnostics, Inc.
ROCHESTER, NY, US
Infrared Laboratory Systems Dba Synermed
WESTFIELD, IN, US
Sensor Health Products, Inc.
CAMBRIDGE Ontario, CA
Medicon Hellas Sa
GERAKAS Attiki, GR
Abbott Laboratories
Lake Forest, IL, US
Sanzay Corporation -
Miami Gardens, FL, US
Sekisui Diagnostics P.e.i. Inc.
CHARLOTTETOWN Prince Edward Island, CA
Biobase Biodustry(shandong)co., Ltd
Jinan Shandong, CN
Teco Diagnostics
ANAHEIM, CA, US
Diamond Diagnostics Inc.
Budapest, HU
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Carolina Liquid Chemistries
Brea, CA, US
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti
Istanbul, TR
Beckman Coulter, Inc.
CARLSBAD, CA, US
510(k) clearances
116 clearances for this product code
- Elan Holdings, Inc.Oct 18, 1999
K992846 · HICHEM TOTAL PROTEIN REAGENT
- Diagnostic Chemicals , Ltd.Mar 2, 1998
K973108 · TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
- Exigent Diagnostics, Inc.Feb 4, 1998
K980042 · CARESIDE TOTAL PROTEIN
- Carolina Liquid Chemistries Corp.May 16, 1997
K971524 · TOTAL PROTEIN OR TP
- Teco DiagnosticsOct 24, 1996
K961864 · CSF/URINE TOTAL PROTEIN
- Solarcare Technologies Corp,Inc.May 30, 1996
K955905 · STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
- Derma Media Lab., Inc.Mar 12, 1996
K955936 · TOTAL PROTEIN REAGENT
- Dupont Medical ProductsAug 11, 1995
K950920 · DUPONT DIMENSION TOTAL PROTEIN METHOD