FDA recall Z-1248-2025

TERRAGENE S.A. · Class II · device

Product

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

US Nationwide distribution in the states of CA and KY.

Key facts

Status
Ongoing
Initiation date
2025-01-15
Report date
2025-03-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Alvear, N/A, Argentina

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1248-2025