One Step pH In Vitro Diagnostic Test Recalled Without FDA Clearance
DFI Co., Ltd. is recalling the One Step pH in vitro diagnostic test 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: This is an FDA Class II recall for an unapproved in vitro diagnostic device distributed without required premarket clearance. No specific injuries, illnesses, or harm have been reported. The hazard is regulatory non-compliance rather than a demonstrated safety defect.
Plain-English summary
DFI Co., Ltd. is recalling the One Step pH in vitro diagnostic test, model REF: 31I4P. The devices were distributed without the required FDA premarket clearance or approval.
The affected product was distributed worldwide, with US distribution in Florida, Pennsylvania, and in England. A total of 7,860 units were distributed under the following lot numbers: 250305, 250415, 250509, 250625, and 250905. The UDI is 08806141303060.
If you have received this device, contact DFI Co., Ltd. Do not use the device until you have confirmed its regulatory status with the manufacturer.
The recalled product
- Product
- One Step pH in vitro diagnostic test REF: 31I4P
- Manufacturer
- DFI Co., Ltd.
- Hazard
- unapproved-device
- regulatory-violation
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: 08806141303060/ Lot: 250305
- 250415
- 250509
- 250625
- 250905
Distribution
Distributed nationwide across the United States.
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