One Step K in vitro diagnostic test recall for missing FDA clearance
DFI Co., Ltd. is recalling One Step K in vitro diagnostic test devices (761 units) because they were distributed without required FDA premarket clearance or approval.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text states no reported illnesses or injuries, and the hazard is regulatory non-compliance (missing premarket clearance) rather than a direct safety or performance defect. Class II recalls without reported adverse events typically fall in the Moderate range per the rubric.
Plain-English summary
DFI Co., Ltd. is recalling One Step K in vitro diagnostic test devices (REF: 81A4) distributed in the United States (in Florida and Pennsylvania) and England. A total of 761 units were affected, with lot numbers 241023, 250625, and 250905.
The devices were distributed without the required FDA premarket clearance or approval. This is a Class II recall.
If you have one of these devices, contact DFI Co., Ltd. for instructions on return or disposal. Consumers with questions should reach out to the manufacturer or consult the FDA.
The recalled product
- Product
- One Step K in vitro diagnostic test REF: 81A4
- Manufacturer
- DFI Co., Ltd.
- Hazard
- regulatory-violation
- unapproved-device
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI:08806141302650/ Lot: 241023
- 250625
- 250905
Distribution
Distributed nationwide across the United States.
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