FDA-Device2025-03-05Class II
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
TERRAGENE S.A.
Hazard
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
Sold states
US Nationwide distribution in the states of CA and KY.
Affected count
914 devices in the U.S.
Manufactured in
Ruta Nacional N 9, Km 280, Cp 2130, Parque Industrial Micropi, Alvear, N/A, Argentina
Products
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1248-2025Don't want to check this manually?
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