Uric Acid in vitro diagnostic test distributed without FDA clearance
DFI Co., Ltd. is recalling its Uric Acid in vitro diagnostic test (REF: 31H0P) because the devices were distributed without required FDA premarket clearance or approval.
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 recall is an FDA Class II device recall for distribution without premarket clearance. No illnesses, injuries, or device malfunctions are reported in the source text; the issue is regulatory compliance. Class II recalls without reported adverse events typically fall in the Moderate range per the rubric.
Plain-English summary
DFI Co., Ltd. is recalling the Uric Acid in vitro diagnostic test (REF: 31H0P) distributed in the United States, including Florida, Pennsylvania, and England. The devices were distributed without required FDA premarket clearance or approval.
The recalled lot numbers are 241023, 250415, 250509, 250617, and 250905. A total of 59,815 units have been distributed.
Consumers and healthcare providers who have these devices should contact DFI Co., Ltd. for further instructions on how to return or manage the recalled products. Laboratories using this test should cease using the recalled lots immediately.
The recalled product
- Product
- Uric Acid in vitro diagnostic test REF: 31H0P
- Manufacturer
- DFI Co., Ltd.
- Affected units
- 59,815
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 (5)
- UDI: 08806141303077/ Lot: 241023
- 250415
- 250509
- 250617
- 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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