ORAcollect RNA: ORE-100 — Class II medical device recall Z-0982-2022
Ongoing recall by DNA Genotek Inc., reported 2022-04-27, distributed nationwide. Evaporation of stabilizing liquid reducing shelf life.
| Recall number | Z-0982-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DNA Genotek Inc., Kanata, Canada |
| Recall initiated | 2022-02-18 |
| Classified | 2022-04-21 |
| Reported by FDA | 2022-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CL, CN, DE, DK, FI, GB, HR, IT, JP, NL, TH, ZA |
| Lot numbers | YJ530 |
Product
ORAcollect RNA: ORE-100
Reason for recall
Evaporation of stabilizing liquid reducing shelf life.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0982-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.