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MEDICAL DEVICE RECALLMODERATE
One Step 10A In Vitro Diagnostic Test
DFI is recalling the One Step 10A in vitro diagnostic test due to a lack of required FDA premarket clearance or approval.
What to do
Stop using the One Step 10A in vitro diagnostic test immediately and contact the manufacturer for further instructions.
Why it was recalled
The devices were distributed without required FDA premarket clearance or approval.
How to identify it
UPC 08806141303497
One Step 10A in vitro diagnostic test
Where it was sold
Distributed in US.
Official source
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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification