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Estrone ELISA
EUROIMMUN Medizinische Labordiagnostika AG · Model EQ 6165-9601-1 · UDI-DI 04049016148388
4
510(k) clearances
0
Adverse events
4
Recalls
12
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-15 | Immunotech A.S. | The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issu |
| 2025-06-12 | Immunotech A.S. | Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might ca |
| 2025-06-12 | Beckman Coulter Inc. | A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coa |
| 2010-04-22 | Beckman Coulter Inc. | Beckman Coulter has confirmed that eight Estrone RIA kit (Ref DSL 8700) lots are inaccurately calibrated to the firm's internal reference calibrator. Lots 992637, 100115A, 100205A |
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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.