TERRAGENE S.A. recalls ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
- Recall date
- January 15, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1248-2025
- FDA classification
- Class II
- Brand / firm
- TERRAGENE S.A.
- Sold / distributed
- US Nationwide distribution in the states of CA and KY.
Why it was recalled
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
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