One Step P in vitro diagnostic test lacks FDA premarket clearance
The One Step P in vitro diagnostic test (REF 8194) was distributed without required FDA premarket clearance or approval. The manufacturer DFI Co., Ltd. is recalling the device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The device was distributed without FDA premarket clearance, which is a regulatory violation. The source text does not report any adverse health consequences, deaths, injuries, or hospitalizations. As a Class II recall with a regulatory rather than safety-hazard basis and no reported harm, this meets the Moderate threshold.
Plain-English summary
DFI Co., Ltd. is recalling the One Step P in vitro diagnostic test (REF 8194) because the devices were distributed without required FDA premarket clearance or approval.
The affected product was distributed nationwide in Florida and Pennsylvania, as well as in England. A total of 1064 units were affected, with lot numbers 241023, 250527, and 250905. The device's UDI is 08806141302025.
Consumers and healthcare providers in possession of this device should stop using it and contact DFI Co., Ltd. for instructions on return or disposal.
The recalled product
- Product
- One Step P in vitro diagnostic test REF: 8194
- Manufacturer
- DFI Co., Ltd.
- Affected units
- 1,064
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:08806141302025/ Lot: 241023
- 250527
- 250905
Distribution
Part of a larger recall action
This product is one of 7 recalled by DFI Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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