Atellica IM Ee2
Estradiol (eE2) Atellica IM - RGT - 100T
5manufacturers in China registered for this device type
3catalogue numbers in this listing
15recalls 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 | CHP |
| Device type | Radioimmunoassay, Estradiol |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1260 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
| Record revised | 2021-11-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store Upright, Protect from Light, Do not freeze, Resuspend.; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10995561 | In distribution | |
| 10995562 | In distribution | |
| 11206250 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Salimetrics | Salimetrics LLC. | 5 |
| MP Biomedicals LLC | Mp Biomedicals, LLC | 4 |
| 17beta-Estradiol Saliva Luminescence Immunoassay | IBL International Gmbh | 4 |
| Elecsys Estradiol III | Roche Diagnostics Gmbh | 3 |
| Alinity | Abbott Ireland | 3 |
| Advia Centaur® eE2 | Siemens Healthcare Diagnostics Inc | 3 |
| Architect | Abbott Ireland | 3 |
| Pantex | Pantex | 2 |
| Estradiol Sensitive Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Salivary Estradiol Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Ultrasensitive Estradiol Elisa | American Laboratory Products Company | 2 |
| 17beta-Estradiol Saliva Elisa | IBL International Gmbh | 2 |
Showing 12 of 58. All products under Radioimmunoassay, Estradiol
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | UDI-DI | 2022-03-03 | Class II | Under Investigation by firm | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results | 2,044 units |
| Siemens Healthcare Diagnostics Inc | UDI-DI | 2022-03-03 | Class II | Under Investigation by firm | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results | 374 units |
| Siemens Healthcare Diagnostics Inc | UDI-DI | 2022-03-03 | Class II | Under Investigation by firm | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results | 230 units |
Recalls
12 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 |
|---|---|---|---|---|---|
| 2022-03-03 | Class II | Under Investigation by firm | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results | 2,315 units | |
| 2022-03-03 | Class II | Under Investigation by firm | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results | 952 units | |
| 2022-03-03 | Class II | Under Investigation by firm | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results | 88 units | |
| 2020-02-05 | Class II | Under Investigation by firm | Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to | 6118 kits | 2021-11-18 |
| 2020-02-05 | Class II | Under Investigation by firm | Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to | 2267 kits | 2021-11-18 |
| 2018-03-21 | Class II | Under Investigation by firm | The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced vol | 197 | 2020-06-12 |
| 2017-06-07 | Class II | Under Investigation by firm | Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) a | 5992 units (US and OUS) | 2019-05-08 |
| 2017-03-21 | Class II | Under Investigation by firm | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, a | 1,697 units | 2018-08-03 |
| 2016-01-13 | Class II | Device Design | The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results. | 9334 units | 2018-01-08 |
| 2016-01-13 | Class II | Device Design | The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results. | 1945 units | 2018-01-08 |
| 2016-01-13 | Class II | Device Design | The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results. | 33604 units | 2018-01-08 |
| 2016-01-13 | Class II | Device Design | The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results. | 9251 units | 2018-01-08 |
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.