TERRAGENE S.A.: Medical Device Recall in 2025 - (Recall #: Z-1248-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.

Product Classification:

Class II

Date Initiated: January 15, 2025

Date Posted: March 5, 2025

Recall Number: Z-1248-2025

Event ID: 96176

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.

Status: Ongoing

Product Quantity: 914 devices in the U.S.

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.

Voluntary or Mandated:

Voluntary: Firm initiated