Atellica™ IM VitD
Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 500T
1manufacturer
2catalogue numbers in this listing
4510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | MRG |
| Device type | System, Test, Vitamin D |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1825 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K133156 |
| Record published | 2021-05-28 |
| Record revised | 2026-03-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Store Upright, Protect from Light, Do not freeze, Resuspend. |
| Distribution end date | 2022-04-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10995720 | In distribution | |
| 11201773 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 6 |
| Access 25(OH) Vitamin D Total | Beckman Coulter, Inc. | 3 |
| Maglumi 25-OH Vitamin D | Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | 3 |
| Architect | Abbott Medical | 3 |
| 1,25 Dihydroxy Vitamin D RIA | Immunodiagnostic Systems Ltd. | 2 |
| Maglumi 2000 25-OH Vitamin D | Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | 2 |
| Alinity | Abbott Ireland | 2 |
| Architect | Abbott Ireland | 2 |
| Elecsys Vitamin D total II | Roche Diagnostics Gmbh | 2 |
| IDS-iSYS 25 VitDS | Immunodiagnostic Systems Ltd. | 2 |
| Elecsys Vitamin D total III | Roche Diagnostics Gmbh | 2 |
| Advia Centaur® VitD | Siemens Healthcare Diagnostics Inc | 1 |
Showing 12 of 50. All products under System, Test, Vitamin D
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200509 | 2020-05-29 |
| K162298 | 2017-03-16 |
| K133156 | 2014-07-24 |
| K110586 | 2011-10-14 |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. 2 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-10-05 | Class II | Device Design | Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples | 69781 kits | 2019-08-29 |
| 2016-10-05 | Class II | Device Design | Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples | 37437 kits | 2019-08-29 |
| 2014-04-10 | Class II | Device Design | Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. | 17,731 kits | 2016-05-27 |
| 2014-04-10 | Class II | Device Design | Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. | 40,266 kits | 2016-05-27 |
| 2014-04-10 | Class II | Device Design | Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. | 12,787 kits | 2016-05-27 |
| 2013-03-13 | Class II | No Marketing Application | Negative bias in patient samples for Vitamin D | 4133 | 2015-03-05 |
| 2013-03-13 | Class II | No Marketing Application | Negative bias in patient samples for Vitamin D | 3871 | 2015-03-05 |
| 2012-02-16 | Not classified | Nonconforming Material/Component | Automatic and system-performed dilution calculation factor for Vitamin D dilutions is incorrect and causes diluted patient samples to under recover by approximately 50%. | 442 units | 2013-10-17 |
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.