medical Class II Updated 2025-03-05

TERRAGENE S.A. recalls ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device,

Recalled Product

ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.


Hazard / Issue

Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.
View official government recall

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