Z-1248-2025 Class II Ongoing
FDA device recall Z-1248-2025 was initiated by TERRAGENE S.A. on January 15, 2025 and is designated Class II. Reason for recall: Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes. The recall status is ongoing. Affected quantity: 914 devices in the U.S..
Recall Details
- Product Type
- Devices
- Report Date
- March 5, 2025
- Initiation Date
- January 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 914 devices in the U.S.
Product Description
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Reason for Recall
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
Distribution Pattern
US Nationwide distribution in the states of CA and KY.
Code Information
Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.