FDA recall, , Moderate risk
DFI One Step and QUCARE In Vitro Diagnostic Tests
The One Step 10A in vitro diagnostic test was distributed without required FDA premarket clearance or approval.
Summary by Recall Canary from the FDA notice
What happened
DFI Co., Ltd., of Gimhae, Korea (the Republic of), recalled several in vitro diagnostic tests, including the One Step K, Uric Acid, Qucare Total Cholesterol, One Step pH, One Step P, One Step 10A, and One Step UTI tests, because the devices were distributed without required FDA premarket clearance or approval. The recall began April 2, 2026, and was classified by the FDA on May 6, 2026. Distribution included Florida, Pennsylvania, and England.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
7 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
One Step K in vitro diagnostic test REF: 81A4
- UDI-DI
- 08806141302650
- Lot code
- 241023
- 250625
- 250905
Uric Acid in vitro diagnostic test REF: 31H0P
- UDI-DI
- 08806141303077
- Lot code
- 241023
- 250415
- 250509
- 250617
- 250905
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
- UDI-DI
- 08806141303060
- Lot code
- BS032501
- BS042502
- BS062501
- BS062502
- BS082501
One Step pH in vitro diagnostic test REF: 31I4P
- UDI-DI
- 08806141303060
- Lot code
- 250305
- 250415
- 250509
- 250625
- 250905
One Step P in vitro diagnostic test REF: 8194
- UDI-DI
- 08806141302025
- Lot code
- 241023
- 250527
- 250905
One Step 10A in vitro diagnostic test
- UDI-DI
- 08806141303497
- Lot code
- 241023
- 250305
- 250415
- 250527
- 250625
- 250905
One Step UTI in vitro diagnostic test REF: 3374
- UDI-DI
- 08806141303480
- Lot code
- 241023
- 250625
- 250905
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Florida, Pennsylvania and the country of England.
- Company
- DFI Co., Ltd.Gimhae, Korea (the Republic of)
- Hazard
- Unapproved product
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98739
- Recall numbers
- Z-2082-2026 to Z-2088-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
