FDAJanuary 15, 2025device
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
terragene
UPCs
0779837577262407798375772877
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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