Notice names this product. DFI Co’s One Step K in vitro diagnostic test REF is named in FDA Class II recall Z-2087-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: The devices were distributed without required FDA premarket clearance or approval. Identifying details: UDI:08806141302650/ Lot: 241023, 250625, 250905. Units affected: 761 units. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
One Step K in vitro diagnostic test REF: 81A4
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
The devices were distributed without required FDA premarket clearance or approval.
Company / brand: DFI Co recalls
Affected product: One Step K in vitro diagnostic test REF recall status
Official ID Z-2087-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.