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ESTR-S-US
CISBIO BIOASSAYS · Model ESTR-S-US · UDI-DI 03770024321586
CHP
Prescription
10
510(k) clearances
727
Adverse events (1 deaths)
31
Recalls
55
Facilities
Description
Radioimmunometric assay kit for the quantitative determination of low levels of estradiol in human samples. Contain enough reagents for 100 tests. For in vitro diagnostic.
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.