DFI Co., Ltd. 2026-05-13 Health serious FDA
Health · FDA · Recall #FDA-Z-2087-2026
One Step K in vitro diagnostic test REF: 81A4 Recall
Issued May 13, 2026 · DFI Co., Ltd.
In May 2026, DFI Co., Ltd. recalled the One Step K in vitro diagnostic test REF: 81A4, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The devices were distributed without required FDA premarket clearance or approval.
What you should do
- 1 Stop using One Step K in vitro diagnostic test REF: 81A4 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact DFI Co., Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- DFI Co., Ltd.
- Category
- Health
- Recall date
- May 13, 2026
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
- Recall number
- FDA-Z-2087-2026
- Made in
- Korea (the Republic of)
- Issuing agency
- FDA
In context
- DFI Co., Ltd. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.