CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report
One Step UTI in vitro diagnostic test recalled by DFI Co
DFI Co is recalling One Step UTI 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-2083-2026
- FDA event ID
- 98739
- Recalling firm
- DFI Co, 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 UTI in vitro diagnostic test REF: 3374
Where it was distributed
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Questions about this recall
Is One Step UTI in vitro diagnostic test recalled?
Yes. DFI Co recalled One Step UTI in vitro diagnostic test on 2 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2083-2026.
Why was it recalled?
The devices were distributed without required FDA premarket clearance or approval.
Which lots are affected?
UDI: 08806141303480/ Lot: 241023, 250625, 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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