Device product
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Z-1248-2025
Product summary
- Firm
- TERRAGENE S.A.
- Event
- Event 96176
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 914 devices in the U.S.
- Official record key
device-enforcement:Z-1248-2025
Official wording
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.
Code information: Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.
Distribution pattern: US Nationwide distribution in the states of CA and KY.
Derived failure modes
-
Unknown
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.