Class II
Medical Device Recall: ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
TERRAGENE S.A. · January 15, 2025
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.
States Affected
NATIONWIDE
Quantity Affected
914 devices in the U.S.
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1248-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.