FDA Device recall Z-1248-2025
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135
- FDA Device
- Class II
- ongoing
- Published 2025-03-05
On 2025-03-05 the FDA classified a Class II recall of ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135 by Terragene, citing error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1248-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-15 |
| Published | 2025-03-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Terragene |
| Distribution | US |
Product
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
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.
Identifiers
| code_info | Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 077983757728…Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1248-2025%22
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