Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab — Class II medical device recall Z-0561-2022
Terminated recall by Gentueri Inc, reported 2022-02-16, distributed in IL, NE, WI. Kits failed sterility testing and showed evidence of contamination.
| Recall number | Z-0561-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gentueri Inc, Verona, WI, United States |
| Recall initiated | 2020-07-06 |
| Classified | 2022-02-04 |
| Reported by FDA | 2022-02-16 |
| Terminated | 2023-12-12 |
| Distributed | IL, NE, WI |
| Quantity | 13,975 units |
| Reason classes | sterility |
| Lot numbers | 1029 |
| Model numbers | 3300-000 |
Product
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Reason for recall
Kits failed sterility testing and showed evidence of contamination.
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-0561-2022. 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.