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.
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: 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.
See all 7 products in this recall →Related recalls
Same manufacturer · DFI Co., Ltd.
See all →- ModerateOne Step K in vitro diagnostic test recall for missing FDA clearance
FDA (Devices) · 2026-05-13
- ModerateOne Step pH In Vitro Diagnostic Test Recalled Without FDA Clearance
FDA (Devices) · 2026-05-13
- ModerateQUCARE Total Cholesterol in vitro Diagnostic Test Recalled
FDA (Devices) · 2026-05-13
- ModerateOne Step 10A In Vitro Diagnostic Test Distributed Without FDA Clearance
FDA (Devices) · 2026-05-13
- ModerateUric Acid in vitro diagnostic test distributed without FDA clearance
FDA (Devices) · 2026-05-13
Same hazard · unapproved distribution
See all →- ModerateReusable hip trial components recalled over missing FDA premarket authorization
FDA (Devices) · 2026-01-28
- ModerateBaxter Seprafilm Adhesion Barrier Recalled for Unapproved Distribution
FDA (Devices) · 2024-05-01
- ModerateVyaire Flexible Patient Circuit 3100A Distributed Without U.S. Approval
FDA (Devices) · 2023-12-13
- HighDual-Trak Clavicle Screws recalled: distributed without FDA pre-market clearance
FDA (Devices) · 2023-01-04
- ModerateLumiQuick Barbiturate Strip Recalled for Unapproved Distribution
FDA (Devices) · 2014-04-16