CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report
One Step P in vitro diagnostic test recalled by DFI Co
DFI is recalling One Step P in vitro diagnostic test, distributed nationwide in the US. The recall was initiated on 2 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2088-2026
- FDA event ID
- 98739
- Recalling firm
- DFI, Gimhae
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Apr 2026
- FDA classified
- 6 May 2026
- Reported
- 13 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 2 Apr 2026 | Recall initiated by company | |
| 6 May 2026 | Classified by FDA | +34 days |
| 13 May 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The devices were distributed without required FDA premarket clearance or approval.
Product as listed by the FDA
One Step P in vitro diagnostic test REF: 8194
Where it was distributed
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Questions about this recall
Why was it recalled?
The devices were distributed without required FDA premarket clearance or approval.
Which lots are affected?
UDI:08806141302025/ Lot: 241023, 250527, 250905
Where was it sold?
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 98739This product is part of a recall event; the main page for the event is One Step K in vitro diagnostic test recalled by DFI Co.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | One Step K in vitro diagnostic test recalled by DFI Co | DFI | Other | Nationwide | |
| CLASS II | Uric Acid in vitro diagnostic test recalled by DFI Co | DFI | Other | Nationwide | |
| CLASS II | Qucare Total Cholesterol in vitro diagnostic test recalled by DFI Co | DFI | Other | Nationwide | |
| CLASS II | One Step pH in vitro diagnostic test recalled by DFI Co | DFI | Other | Nationwide | |
| CLASS II | One Step 10A in vitro diagnostic test recalled by DFI Co | DFI | Other | Nationwide | |
| CLASS II | One Step UTI in vitro diagnostic test recalled by DFI Co | DFI | Other | Nationwide |
More recalls from DFI
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | One Step UTI in vitro diagnostic test recalled by DFI Co | DFI | Other | Nationwide |
| Device | CLASS II | One Step 10A in vitro diagnostic test recalled by DFI Co | DFI | Other | Nationwide |
| Device | CLASS II | One Step pH in vitro diagnostic test recalled by DFI Co | DFI | Other | Nationwide |
| Device | CLASS II | Qucare Total Cholesterol in vitro diagnostic test recalled by DFI Co | DFI | Other | Nationwide |
| Device | CLASS II | Uric Acid in vitro diagnostic test recalled by DFI Co | DFI | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,663| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |