Atellica CH Total Protein_2
Atellica CH Total Protein (TP_2) RGT 3700T
3manufacturers in China registered for this device type
2catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Zhejiang (1), Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | CEK |
| Device type | Biuret (Colorimetric), Total Protein |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1635 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-03-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 15 to 25 °C; Storage environment temperature 15 to 25 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 11645755 | 2 | In distribution | |
| 11537228 | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 17 |
| Synermed® | Infrared Laboratory Systems LLC | 10 |
| JAS Diagnostics | Drew Scientific, Ltd. | 6 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 5 |
| AU | Beckman Coulter, Inc. | 5 |
| Pointe Scientific, Inc. Total Protein | Horiba Instruments Incorporated | 5 |
| Synchron | Beckman Coulter, Inc. | 3 |
| Total Protein 2 (TP 2) | Randox Laboratories Limited | 3 |
| Total Protein | Roche Diagnostics Gmbh | 3 |
| Alinity | Abbott Ireland | 2 |
| Pointe Total Protein Reagent | Horiba Instruments Incorporated | 2 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
Showing 12 of 61. All products under Biuret (Colorimetric), Total Protein
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-08-11 | Class II | Under Investigation by firm | Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results. | 11,811 units |
| 2024-07-29 | Class II | Under Investigation by firm | The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents. | 143 units (17 US, 126 OUS) |
| 2024-07-29 | Class II | Under Investigation by firm | The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents. | 1,164 units (229 US, 935 OUS) |
| 2023-01-27 | Class II | Under Investigation by firm | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results | 13071 units |
| 2021-09-20 | Class II | Software design | 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 cons | 246 (US); 689 (OUS) |
| 2021-09-20 | Class II | Software design | 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 consider | 1402 (US); 2941 (OUS) |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.