FDAFDA · Food and drugs·Recall number Z-1248-2025
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Published March 5, 2025 · Recall initiated: January 15, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- TERRAGENE S.A.
- Distributor
- US Nationwide distribution in the states of CA and KY.
- Lot
- Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Argentina
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