DFI recalls One Step P in vitro diagnostic test REF: 819:1023, 250527, 250905 due to lack of FDA premarket approval. Consumers should check serial numbers for affected units.
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd. is recalling One Step P in vitro diagnostic tests that were distributed without required FDA premarket clearance. This means the tests could be used without proper regulatory approval, potentially leading to inaccurate results.
The tests were distributed without FDA premarket clearance, meaning they were not approved for safety and effectiveness before being sold. This could lead to inaccurate diagnostic results if used in medical settings.
Anyone who purchased the One Step P diagnostic test with the specified serial numbers or lot codes. Laboratory users and healthcare providers are most at risk due to potential inaccurate test results.
Check the serial number on the test package, which starts with 08806141302025. Affected units have lot codes 241023, 250527, or 250905.
Look for the serial number starting with 08806141302025 on the test package.
The tests were distributed without required FDA premarket clearance or approval.
Check the serial number and lot code to see if it's affected. If it is, contact DFI for further instructions.
The recall is due to lack of FDA premarket approval, which could lead to inaccurate test results but does not pose a direct safety risk like injury or fire.
We’ve drafted a message you can send DFI to request your refund or repair — edit it as you like.
Subject: Recall Z-2088-2026 — DFI DFI Hello, I own a DFI that is covered by recall Z-2088-2026 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.
