DFI recalls One Step K diagnostic test (REF 81A4) due to lack of FDA premarket approval. Affected units sold from 2024-2025; stop using immediately if you have this product.
The devices were distributed without required FDA premarket clearance or approval.
DFI recalled its One Step K in vitro diagnostic test (REF : 81A4) because it was distributed without required FDA premarket clearance. This means the product may not be safe for use as intended.
The product was distributed without required FDA premarket clearance or approval. This means the test may not be safe for use as intended, potentially leading to inaccurate results or health risks.
People who purchased or use the One Step K diagnostic test (REF: 81A4) are affected. Those using the test for medical purposes without proper regulatory approval are at higher risk.
Check for the product name 'One Step K in vitro diagnostic test' and reference number 81A4. The units were sold with specific lot numbers: 241023, 250625, and 250905.
If you have the One Step K in vitro diagnostic test (REF: 81A4), stop using it right away.
The product was distributed without required FDA premarket clearance or approval.
The affected model is One Step K in vitro diagnostic test REF: 81A4 with lot numbers 241023, 250625, and 250905.
The recall record does not specify a return process or deadline for returning the product.
We’ve drafted a message you can send DFI to request your refund or repair — edit it as you like.
Subject: Recall Z-2087-2026 — DFI DFI Hello, I own a DFI that is covered by recall Z-2087-2026 from DFI. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
