FDA Device recall Z-2087-2026
One Step K in vitro diagnostic test REF: 81A4
- FDA Device
- Class II
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class II recall of One Step K in vitro diagnostic test REF: 81A4 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-2087-2026 |
| 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 K in vitro diagnostic test REF: 81A4
Reason
The devices were distributed without required FDA premarket clearance or approval.
Identifiers
| code_info | UDI:08806141302650/ Lot: 241023, 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-2087-2026%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.