Class II

Medical Device Recall: One Step 10A in vitro diagnostic test

DFI Co., Ltd. · April 2, 2026

Reason for Recall

The devices were distributed without required FDA premarket clearance or approval.

Distribution

Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.

States Affected

NATIONWIDE

Quantity Affected

6533 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2082-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.