TERRAGENE S.A ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135 recall — FDA Z-1248-2025
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
Overview of recall records associated with TERRAGENE S.A., including dates, categories and classifications where available.
Classification mix: Class II: 2.
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
This page summarizes recall records in which the official source identifies TERRAGENE S.A. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.