Atellica™ CH TP
Total Protein (TP) - Atellica™ CH - RGT - 7400T
3manufacturers in China registered for this device type
1catalogue number
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 | 2017-10-06 |
| Record revised | 2026-02-26 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 25 °C |
| Distribution end date | 2025-12-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11097604 | Withdrawn |
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 Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | UDI-DI | 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 |
Recalls
5 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) |
| 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.