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Salivary Estradiol ELISA
DRG International Inc · Model SLV-4188 · UDI-DI 00840239041883
CHP
Prescription
10
510(k) clearances
719
Adverse events (1 deaths)
31
Recalls
55
Facilities
Description
Enzyme immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
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 potential delayed result |
| 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 misinterpret a patient as p |
| 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 misinterpret a patient as p |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.