Product Wiki · Recalls · U.S. FDA — Device Enforcement

One Step P in vitro diagnostic test REF: 8194 — recall Z-2088-2026

U.S. FDA — Device Enforcement · Korea (the Republic of) · 2026-04-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2088-2026
Date of alert
2026-04-02
Country / jurisdiction
Korea (the Republic of)
Risk level
Class II
Risk type
recall
Brand
DFI Co., Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
08806141302025
Reported risk: The devices were distributed without required FDA premarket clearance or approval.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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