Home › Device types › CEK
Biuret (Colorimetric), Total Protein
FDA product code CEK · Class 2 · Clinical Chemistry
126
Registered devices
93
Adverse events
10
Recalls
116
510(k) clearances
Devices with this code
TOTAL PROTEIN (TP) — RANDOX LABORATORIES LIMITEDSynchron — Beckman Coulter, Inc.TOTAL PROTEIN — SEKISUI DIAGNOSTICS, LLCPiccolo General Chemistry 13 — ABAXIS, INC.Pointe Scientific, Inc. Total Protein — HORIBA INSTRUMENTS INCORPORATEDPointe Scientific, Inc. Total Protein — HORIBA INSTRUMENTS INCORPORATEDJAS Diagnostics — DREW SCIENTIFIC, INC.Synermed® — INFRARED LABORATORY SYSTEMS LLCJAS Diagnostics — DREW SCIENTIFIC, INC.Dimension Vista® Flex® reagent cartridge TP — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT IRELANDBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.CAROLINA LIQUID CHEMISTRIES CORP.® TP REAGENT PRODUCT NO. DT217 — CAROLINA LIQUID CHEMISTRIES CORPORATIONTotal Protein Reagent — CLINICAL DIAGNOSTIC SOLUTIONS, INC.ADVIA® Chemistry Total Protein Reagents Concentrated TP_c — Siemens Healthcare Diagnostics Inc.Synermed® — INFRARED LABORATORY SYSTEMS LLCTotal Protein Gen.2 — Roche Diagnostics GmbHABX PENTRA TOTAL PROTEIN CP — HORIBA ABX SASBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.SYNCHRON CX® TOTAL PROTEIN REAGENT KIT 88816 — CAROLINA LIQUID CHEMISTRIES CORPORATIONIDG/Sanzay — IDG/SANZAY CorporationSynermed® — INFRARED LABORATORY SYSTEMS LLCBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-11 | Siemens Healthcare Diagnostics, Inc. | Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results. |
| 2024-07-29 | Siemens Healthcare Diagnostics, Inc. | The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents. |
| 2024-07-29 | Siemens Healthcare Diagnostics, Inc. | The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents. |
| 2023-01-27 | Siemens Healthcare Diagnostics, Inc. | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results |
| 2021-09-20 | Siemens Healthcare Diagnostics, Inc. | The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c |
| 2021-09-20 | Siemens Healthcare Diagnostics, Inc. | The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) |
| 2020-12-15 | Ortho Clinical Diagnostics Inc | Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides |
| 2020-12-15 | Ortho Clinical Diagnostics Inc | Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| 2003-03-26 | Ortho-Clinical Diagnostics | Slides may exhibit random, elevated imprecision of results. |
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