One Step 10A In Vitro Diagnostic Test Distributed Without FDA Clearance
DFI Co., Ltd. is recalling the One Step 10A in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval. The recall affects 6533 units distributed nationwide in Florida, Pennsylvania, and England.
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 source indicates FDA Class II classification and the hazard is regulatory non-compliance (lack of premarket clearance). The source text does not report any illnesses, injuries, or failures of the device itself, making this a precautionary regulatory recall rather than a safety emergency.
Plain-English summary
DFI Co., Ltd. is recalling the One Step 10A in vitro diagnostic test (UDI: 08806141303497, affected lot numbers: 241023, 250305, 250415, 250527, 250625, 250905). A total of 6533 units were distributed without obtaining the required FDA premarket clearance or approval.
The devices were distributed to facilities in Florida, Pennsylvania, and England. Users of this device should discontinue use and contact the manufacturer or FDA for further instructions.
This recall is classified as FDA Class II and was assigned recall number Z-2082-2026.
The recalled product
- Product
- One Step 10A in vitro diagnostic test
- Manufacturer
- DFI Co., Ltd.
- Affected units
- 6,533
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 (6)
- UDI: 08806141303497/ Lot: 241023
- 250305
- 250415
- 250527
- 250625
- 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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