AutoDELFIA Unconjugated Estriol (uE3) kit
Wallac Oy · Model B095-101U · UDI-DI 06438147355013
CGI
Prescription
10
510(k) clearances
16
Adverse events
2
Recalls
18
Facilities
Description
Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-08-26 | Beckman Coulter Inc. | Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results. |
| 2009-12-08 | Beckman 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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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.