One Step UTI in vitro diagnostic test recalled for missing FDA approval
DFI Co., Ltd. is recalling the One Step UTI in vitro diagnostic test (REF: 3374) because it was 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: FDA Class II recalls without reported adverse events or injuries typically fall in the Moderate range. The hazard here is regulatory non-compliance rather than an identified safety defect or reported harm.
Plain-English summary
DFI Co., Ltd. is recalling the One Step UTI in vitro diagnostic test (REF: 3374) due to distribution without required FDA premarket clearance or approval. The affected product was distributed nationwide in Florida and Pennsylvania, as well as in England.
Consumers who have this device should stop using it and contact their healthcare provider or DFI Co., Ltd. for further instructions.
The recalled product
- Product
- One Step UTI in vitro diagnostic test REF: 3374
- Manufacturer
- DFI Co., Ltd.
- Hazard
- unauthorized-distribution
- missing-premarket-approval
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: 08806141303480/ Lot: 241023
- 250625
- 250905
Distribution
Distributed nationwide across the United States.
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