DFI recalls One Step UTI diagnostic test (REF: 3374) due to lack of FDA premarket approval. Affected units sold with UDI 08806141303480 and lots 241023, 2:50625, 250905.
The devices were distributed without required FDA premarket clearance or approval.
DFI recalls its One Step UTI in vitro diagnostic test (REF: 3374) because it was distributed without required FDA premarket clearance. This means the product may not be safe for use without proper regulatory approval.
The test was distributed without required FDA premarket clearance or approval. This means the product may not meet safety standards for medical use, potentially leading to inaccurate results or health risks if used improperly.
Users of the One Step UTI test with UDI 08806141303480 and lots 241023, 250625, 250905 are affected. Healthcare providers and individuals using the test for urine infections are most at risk.
Check the product's UDI code (08806141303480) and lot numbers (241023, 250625, 250905) on the packaging. The test is sold under the brand DFI Co., Ltd.
Identify the UDI code (08806141303480) and lot numbers (241023, 250625, 250905) on the test packaging.
The official recall states the test was distributed without required FDA premarket clearance, so it may not be safe for use.
The recall does not specify a remedy, so check the product details and contact DFI Co., Ltd. for further instructions.
Look for the UDI code 08806141303480 and lot numbers 241023, 250625, or 250905 on the packaging.
We’ve drafted a message you can send DFI to request your refund or repair — edit it as you like.
Subject: Recall Z-2083-2026 — DFI DFI Hello, I own a DFI that is covered by recall Z-2083-2026 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.
