FDAApril 2, 2026device
One Step K in vitro diagnostic test REF: 81A4
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The devices were distributed without required FDA premarket clearance or approval.
What to do
FDA enforcement status: Ongoing
Brands named
dfi
UPCs
08806141302650
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOne Step 10A in vitro diagnostic test2026-04-02
- FDAUric Acid in vitro diagnostic test REF: 31H0P2026-04-02
- FDAOne Step P in vitro diagnostic test REF: 81942026-04-02
- FDAOne Step UTI in vitro diagnostic test REF: 33742026-04-02
- FDAOne Step pH in vitro diagnostic test REF: 31I4P2026-04-02
- FDAQUCARE Total Cholesterol in vitro diagnostic test REF: 64072026-04-02
- FDA100% Org. Sesame Seeds natural, 50 LBS, Product of Uganda The sesame seeds are packed in multi ply paper bags.2016-10-26
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