TERRAGENE S.A. Recall 96176
Description: ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
TERRAGENE S.A. Recall 96176 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1248-2025 |
| Event ID | 96176 |
| Event Description | ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA and KY. |
| Quantity | 914 devices in the U.S. |
| Recall Reason | Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes. |
| Device Classification | 20250305 |
| Device Code Info | Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0. |
| Center Classification Date | 20250227 |
| Recall Initiation Date | 20250115 |
| Recalling Firm | TERRAGENE S.A. |
| Initial Notification | Letter |
| Similar To |