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AutoDELFIA Neonatal Thyroxine (T4) kit

Wallac Oy · Model B065-01C · UDI-DI 06438147179602

CDX
10
510(k) clearances
100
Adverse events
1
Recalls
13
Facilities

Description

Time-resolved fluoroimmunoassay for the quantitative determination of thyroxine (T4) in dried blood.

Recalls

DateFirmReason
2025-06-04DRG International, Inc.An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the

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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.