DFI Co., Ltd. Uric Acid in vitro diagnostic test REF: 31H0P recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
The hazard: Device safety concern
This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.
What the notice says: The devices were distributed without required FDA premarket clearance or approval.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-2086-2026
- Published
- May 13, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- DFI Co., Ltd.
- Product type
- Medical devices
- Units affected
- 59815 units
- Distribution
- Nationwide
- Made in
- Korea (the Republic of)
- Lot / code info
- UDI: 08806141303077/ Lot: 241023, 250415, 250509, 250617, 250905
- UPC codes
- 08806141303077
Products covered by this recall
Uric Acid in vitro diagnostic test REF: 31H0P
Check your product
The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 08806141303077
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 241023
- 250415
- 250509
- 250617
- 250905 — 59815 units
Model or item number
On the rating label, the box or the instruction sheet.
- 31H0P — UDI
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
DFI Co., Ltd. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- Report device problems to the FDA through MedWatch.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
- Ask the supplier or clinic that provided it what the remedy is in your case.
Replacements, repairs and reimbursement
Device remedies run through the supply chain, so the route depends on who sold you the unit.
- Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
- If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
- Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
- Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.
Company contact: DFI Co., Ltd. — 388-25 Gomo-Ro, Gimhae
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was DFI Co., Ltd. medical devices recalled?
The devices were distributed without required FDA premarket clearance or approval. The devices were distributed without required FDA premarket clearance or approval.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 08806141303077; lot code 241023, 250415, 250509; model number 31H0P — UDI. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
Where was the recalled product sold?
It was distributed nationwide.
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