Vitros
VITROS Immunodiagnostic Products Total T4 Reagent Pack
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
4recalls on this code
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Ortho-Clinical Diagnostics, Inc., United States |
|---|---|
| FDA product code | KLI |
| Device type | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1700 |
| 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 |
|---|---|---|
| 8744468 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Architect | Abbott Ireland | 4 |
| DRI Thyroxine (T4) | Microgenics Corporation | 2 |
| Immulite® 2000 Systems TT4 Total T4 | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Alinity | Abbott Ireland | 2 |
| Immulite®/Immulite® 1000 Systems T4 Total T4 | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Total Thyroxine (T4) Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 1 |
| Access Total T4 | Beckman Coulter, Inc. | 1 |
| Total Thyroxine (tT4) Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 1 |
| ACE | Alfa Wassermann | 1 |
| Cedia T4 Assay | Microgenics Corporation | 1 |
| AIA-Pack T4 Calibrator SET | Tosoh Corp. | 1 |
| ST AIA-Pack T4 | Tosoh Corp. | 1 |
Showing 12 of 30. All products under Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160495 | 2016-10-18 |
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 | Closed |
|---|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 2020-03-10 | Class III | Under Investigation by firm | The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations. | 3181 | 2022-09-26 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2016-06-02 | Class II | Under Investigation by firm | Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack storage limit of <= 8 weeks that is located in the Instructions | US: 12,015; Foreign: 55 Sales Units to Canada, 223 Sales Uni | 2018-06-08 |
| 2014-02-20 | Class II | Other | Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results. | 583 units Total (357 units domestically & 226 units internat | 2017-04-19 |
| 2005-03-15 | Not classified | Other | Potential for positively biased results in QC and patient samples. | Domestic – 1359; International – 840 | 2006-02-10 |
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.