[Recalled] One Step P in vitro diagnostic test REF: 8194 — The devices were distributed without required FDA premarket clearance or approv… | FDA 2026-04-02

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The devices were distributed without required FDA premarket clearance or approval.

This Class II recall concerns device products distributed in Korea (the Republic of) and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from DFI Co., Ltd.

• One Step K in vitro diagnostic test REF: 81A4 — Class II
• Uric Acid in vitro diagnostic test REF: 31H0P — Class II
• QUCARE Total Cholesterol in vitro diagnostic test REF: 6407 — Class II
• One Step pH in vitro diagnostic test REF: 31I4P — Class II
• One Step 10A in vitro diagnostic test — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.