Home / Recalls / TERRAGENE S.A. / Z-1248-2025

Z-1248-2025 Class II Ongoing

Recalled by TERRAGENE S.A. — Alvear, N/A

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.