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TERRAGENE S.A. recalls ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Recalled March 5, 2025 · FDA recall Z-1248-2025 · 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. · FDA Class II
Units
914 devices in the U.S.
Sold at
US Nationwide distribution in the states of CA and KY.
Description
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
Product
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Manufacturer(s)
TERRAGENE S.A.
Made in
Argentina
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →