FDA Device recall Z-2082-2026
One Step 10A in vitro diagnostic test
- FDA Device
- Class II
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class II recall of One Step 10A in vitro diagnostic test by Dfi, citing the devices were distributed without required FDA premarket clearance or approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2082-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-02 |
| Published | 2026-05-13 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Dfi |
| Distribution | US |
Product
One Step 10A in vitro diagnostic test
Reason
The devices were distributed without required FDA premarket clearance or approval.
Identifiers
| code_info | UDI: 08806141303497/ Lot: 241023, 250305, 250415, 250527, 250625, 250905 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2082-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.