DFI Co., Ltd. recalls Uric Acid in vitro diagnostic test REF: 31H0P due to distribution without required FDA premarket clearance. Affected units include specific lot numbers.
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd. is recalling Uric Acid in vitro diagnostic test kits with reference number 31H0P because they were distributed without the necessary FDA premarket clearance. This means the products may not be safe for use as intended.
The test kits were distributed without required FDA premarket clearance, which means they might not meet safety and performance standards. This could lead to inaccurate test results or other issues if used without proper regulatory approval.
Healthcare providers and labs that purchased the Uric Acid test kits with reference number 31H0P and specific lot numbers are likely affected. Individuals using these kits for medical testing may be at risk if they have the recalled products.
Check for the reference number 31H0P on the test kits. Affected lots include 241023, 250415, 250509, 250617, and 250905. The unique device identifier (UDI) is 08806141303077.
Look for the reference number 31H0P and the specific lot numbers listed: 241023, 250415, 250509, 250617, 250905.
The test kits were distributed without required FDA premarket clearance, which means they may not meet safety and performance standards.
Check the reference number and lot numbers to see if your kit is affected. If it is, contact DFI Co., Ltd. for further instructions.
The recall is due to missing FDA clearance, which could lead to inaccurate test results, but no specific safety risks like injury are mentioned.
We’ve drafted a message you can send DFI to request your refund or repair — edit it as you like.
Subject: Recall Z-2086-2026 — DFI DFI Hello, I own a DFI that is covered by recall Z-2086-2026 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.
