Home › Device types › CHP
Radioimmunoassay, Estradiol
FDA product code CHP · Class 1 · Clinical Chemistry
85
Registered devices
719
Adverse events
31
Recalls
50
510(k) clearances
Devices with this code
Ultrasensitive Estradiol ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.17beta-Estradiol Saliva ELISA — IBL International GmbHIonify Steroids 1 — Roche Diagnostics GmbHSalimetrics — SALIMETRICS, LLCAtellica IM eE2 — Siemens Healthcare Diagnostics Inc.Salimetrics — SALIMETRICS, LLCST AIA-PACK hsE2 SAMPLE DILUTING SOLUTION — TOSOH CORPORATIONElecsys Estradiol III — Roche Diagnostics GmbH17beta-Estradiol Saliva Luminescence Immunoassay — IBL International GmbHMP Biomedicals LLC — Mp Biomedicals, LLCEstradiol ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungIMMULITE® 1000 Systems E2 CONTROL Estradiol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDEstradiol (serum) — DRG International IncSalimetrics — SALIMETRICS, LLCSalivary Estradiol ELISA — DRG International IncEstradiol (serum) ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAtellica IM eE2 DIL — Siemens Healthcare Diagnostics Inc.Alinity — ABBOTT IRELANDEstradiol Sensitive ELISA — DRG International IncSalimetrics — SALIMETRICS, LLCIMMULITE® 2000 Systems E2 Estradiol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSalivary Estradiol HS ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungEstradiol ELISA — DRG International IncUltrasensitive Estradiol ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-03-03 | Siemens Healthcare Diagnostics, Inc. | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-03-03 | Siemens Healthcare Diagnostics, Inc. | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-03-03 | Siemens Healthcare Diagnostics, Inc. | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-03-03 | Siemens Healthcare Diagnostics, Inc. | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-03-03 | Siemens Healthcare Diagnostics, Inc. | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-03-03 | Siemens Healthcare Diagnostics, Inc. | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote |
| 2020-02-05 | Siemens Healthcare Diagnostics, Inc. | Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinte |
| 2020-02-05 | Siemens Healthcare Diagnostics, Inc. | Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinte |
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