Vitros
VITROS Immunodignostic Products Total T3 II Reagent Pack
5manufacturers in China registered for this device type
3catalogue numbers in this listing
2recalls 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 | Ortho-Clinical 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 |
| Premarket notification | Exempt |
| Record published | 2016-08-10 |
| Record revised | 2025-02-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Do not freeze; Storage environment temperature 2 to 8 °C |
| Packaging | Case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1322528 | In distribution | |
| 1315589 | In distribution | |
| 6808888 | 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 |
| Atellica IM T3 | Siemens Healthcare Diagnostics Inc | 3 |
| Advia Centaur® FT3 | Siemens Healthcare Diagnostics Inc | 3 |
| Free Triiodothyronine (fT3) Elisa | DRG International, Inc. | 3 |
| Atellica IM T3/T4/VB12 ANC RGT | Siemens Healthcare Diagnostics Inc | 2 |
Showing 12 of 78. All products under Radioimmunoassay, Total Triiodothyronine
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 |
|---|---|---|---|---|---|---|
| Quidelortho | UDI-DI | 2024-04-09 | Class II | Under Investigation by firm | T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, cl | 21268 units |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-05-06 | Class III | Error in labeling | The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels. | Domestic: 898 units | 2017-09-13 |
| 2006-03-28 | Not classified | Other | Firm received complaints of biased results when using VITROS Signal Reagent, Lots 8350 and 8530. VITROS Signal Reagent is used with the VITROS Immunodiagnostic ECi/ECiQ laboratory system, and when used may produce inaccurate test results i | 2000 | 2007-12-14 |
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.