TERRAGENE S.A.: ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.

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.

Details from the source

Reason for recall: Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes. Distribution: US Nationwide distribution in the states of CA and KY. Quantity: 914 devices in the U.S. Lot/code info: Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.

UPC codes

07798375772624, 07798375772877

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.