Atellica IM T3/T4/VB12 ANC RGT
T3/T4/VB12 Ancillary Reagent Atellica IM – CAL (2PK) 2 x 25mL
5manufacturers in China registered for this device type
2catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Jilin (1), Hebei (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
| Beijing Hotgen Biotech Co., Ltd. | Beijing | Beijing | Manufacturer | 13 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | CDP |
| Device type | Radioimmunoassay, Total Triiodothyronine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1710 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K913646 |
| Record published | 2018-02-06 |
| Record revised | 2023-06-09 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store upright; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10995682 | 2 | In distribution | |
| 10995683 | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Architect | Abbott Ireland | 9 |
| Alinity | Abbott Ireland | 5 |
| Elecsys FT3 III | Roche Diagnostics Gmbh | 4 |
| Elecsys T3 | Roche Diagnostics Gmbh | 4 |
| Advia Centaur® T3 | Siemens Healthcare Diagnostics Inc | 3 |
| Free Triiodothyronine (fT3) Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 3 |
| Total T3 125I RIA Kit | Mp Biomedicals, LLC | 3 |
| Atellica IM FT3 | Siemens Healthcare Diagnostics Inc | 3 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 3 |
| Atellica IM T3 | Siemens Healthcare Diagnostics Inc | 3 |
| Advia Centaur® FT3 | Siemens Healthcare Diagnostics Inc | 3 |
| Free Triiodothyronine (fT3) Elisa | DRG International, Inc. | 3 |
Showing 12 of 78. All products under Radioimmunoassay, Total Triiodothyronine
Recalls
3 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 | Closed |
|---|---|---|---|---|---|
| 2017-07-28 | Class II | Under Investigation by firm | Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT system. | 33,298 | 2019-04-03 |
| 2013-08-27 | Class II | Nonconforming Material/Component | Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the I | 4695 kits in total | 2017-02-28 |
| 2013-08-27 | Class II | Nonconforming Material/Component | Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the I | 2201 kits in total | 2017-02-28 |
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.