FDA Device recall Z-0982-2022
ORAcollect RNA: ORE-100
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of ORAcollect RNA: ORE-100 by Dna Genotek, citing evaporation of stabilizing liquid reducing shelf life.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0982-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-18 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Dna Genotek |
| Distribution | US |
Product
ORAcollect RNA: ORE-100
Reason
Evaporation of stabilizing liquid reducing shelf life.
Identifiers
| code_info | Lot: YJ530 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0982-2022%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.