TERRAGENE S.A.: Device Recall
Recall #Z-1248-2025 · 01/15/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1248-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- TERRAGENE S.A.
- Status
- Ongoing
- Date Initiated
- 01/15/2025
- Location
- Alvear, N/A, Argentina
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 914 devices in the U.S.
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.
Product Description
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Distribution Pattern
US Nationwide distribution in the states of CA and KY.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.