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Free Estriol ELISA

EUROIMMUN Medizinische Labordiagnostika AG · Model EQ 6167-9601 · UDI-DI 04049016147602

CGI
10
510(k) clearances
16
Adverse events
2
Recalls
18
Facilities

Recalls

DateFirmReason
2020-08-26Beckman Coulter Inc.Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
2009-12-08Beckman Coulter Inc.The recall was initiated because Beckman Coulter has confirmed customer reports that a single lot of Access Unconjugated Estriol reagent (PIN 33570) may produce suppressed patient

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Data 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.