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SPOTCHECK

ASTORIA-PACIFIC, INC. · Model 80-4500-13K · UDI-DI 00725609000069

KQP Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
2
Facilities

Description

Uridyltransferase 50 Hour Reagent Kit

Recalls

DateFirmReason
2026-05-18WALLAC OYReduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.

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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.