DFI Co., Ltd. One Step K in vitro diagnostic test REF: 81A4 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
A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
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-2087-2026
- 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
- 761 units
- Distribution
- Nationwide
- Made in
- Korea (the Republic of)
- Lot / code info
- UDI:08806141302650/ Lot: 241023, 250625, 250905
- UPC codes
- 08806141302650
Products covered by this recall
One Step K in vitro diagnostic test REF: 81A4
Check your product
The notice names 5 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.
- 08806141302650
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 241023
- 250625
- 250905 — 761 units
Model or item number
On the rating label, the box or the instruction sheet.
- 81A4 — 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. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
Claiming on a recalled device
Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.
- Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
- Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
- If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
- Log the date, the name and the reference number of every call. Device recalls can run for months.
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 08806141302650; lot code 241023, 250625, 250905 — 761 units; model number 81A4 — 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?
Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
Where was the recalled product sold?
It was distributed nationwide.
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