TERRAGENE S.A. Recall: ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73

Name: TERRAGENE S.A. Recall: ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73
Creator: RecallGuard

TERRAGENE S.A. Recall: ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: TERRAGENE S.A.; Product: ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.; Reason for recall: Error in the IFU lists an inco

Recalling firm	TERRAGENE S.A.
Product	ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
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.
Classification	Class II (moderate — may cause temporary or reversible health consequences)
Status	Ongoing
Distribution	US Nationwide distribution in the states of CA and KY.
Recall initiated	20250115
Recall number	Z-1248-2025
Category	device
State	N/A
Country	Argentina

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