One Step K in vitro diagnostic test recall
One Step K in vitro diagnostic test REF: 81A4
Why was One Step K in vitro diagnostic test recalled?
The devices were distributed without required FDA premarket clearance or approval.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI:08806141302650/ Lot: 241023, 250625, 250905
- Product
- One Step K in vitro diagnostic test REF: 81A4
- Recalling firm
- DFI Co., Ltd.
- Quantity
- 761 units
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
- Recall date
- May 13, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)