DFI recalls One Step pH test kits (REF: 31I4P) sold without FDA premarket approval. Consumers should check lot numbers for affected units.
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd. is recalling One Step pH in vitro diagnostic test kits that were distributed without required FDA premarket clearance. This means the products may not be safe for use as intended.
The test kits were distributed without proper FDA premarket clearance or approval. This means the products may not meet safety standards and could lead to inaccurate results or health risks if used improperly.
Anyone who purchased the One Step pH test kits with lot numbers 250305, 250415, 250509, 250625, or 250905. Users of these kits are at risk if they rely on the test results for medical decisions.
Check the lot numbers on the packaging: 250305, 250415, 250509, 250625, or 250905. The product reference code is 31I4P.
Look for lot numbers 250305, 250415, 250509, 250625, or 250905 on the packaging.
The devices were distributed without required FDA premarket clearance or approval.
Check the lot number on the packaging. If it matches the affected lots, contact DFI Co., Ltd. for instructions.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send DFI to request your refund or repair — edit it as you like.
Subject: Recall Z-2084-2026 — DFI DFI Hello, I own a DFI that is covered by recall Z-2084-2026 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.
