Class II — TERRAGENE S.A.
| Recalling firm | Terragene SA |
|---|---|
| Registered facility | TERRAGENE SA (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 | ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135. |
| Quantity | 914 devices in the U.S. |
| Distribution | US Nationwide distribution in the states of CA and KY. |
| Initiated | 2025-01-15 |
| Classified | 2025-02-27 |
| Recall number | Z-1248-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — TERRAGENE S.A. (Z-1248-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96176/
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