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

Recall Z-2082-2026 — One Step 10A in vitro diagnostic test

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

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2082-2026
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)
08806141303497
Reported risk: The devices were distributed without required FDA premarket clearance or approval.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.