Pantex
Pantex · Model N/A · UDI-DI 00850039602467
10
510(k) clearances
719
Adverse events (1 deaths)
31
Recalls
55
Facilities
Description
Direct Salivary 17ß-Estradiol Enzyme Immunoassay (1)
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.