FDA Device recall Z-0561-2022
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
- FDA Device
- Class II
- terminated
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class II recall of Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab by Gentueri, citing kits failed sterility testing and showed evidence of contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0561-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-06 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Gentueri |
| Distribution | IL, NE, WI |
Product
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Reason
Kits failed sterility testing and showed evidence of contamination.
Identifiers
| code_info | CAT#: 3300-000; Lot No.: 1029. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0561-2022%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.