Gentueri Inc Recall 89336
Description: Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Gentueri Inc Recall 89336 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0561-2022 |
| Event ID | 89336 |
| Event Description | Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab |
| Product Type | Devices |
| Distribution | Domestic: Illinois, Nebraska, and Wisconsin. |
| Quantity | 13,975 units (2 mL in a 15 mL conical tube) |
| Recall Reason | Kits failed sterility testing and showed evidence of contamination. |
| Device Classification | 20220216 |
| Device Code Info | CAT#: 3300-000; Lot No.: 1029. |
| Center Classification Date | 20220204 |
| Recall Initiation Date | 20200706 |
| Recalling Firm | Gentueri Inc |
| Initial Notification | |
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