ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device — Class II medical device recall Z-1248-2025
Ongoing recall by TERRAGENE S.A., reported 2025-03-05, distributed nationwide. Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incu
| Recall number | Z-1248-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TERRAGENE S.A., Alvear, N/A, Argentina |
| Recall initiated | 2025-01-15 |
| Classified | 2025-02-27 |
| Reported by FDA | 2025-03-05 |
| Distributed | Nationwide (US) |
| Quantity | 914 devices |
| UPC / GTIN / UDI-DI | 07798375772624, 07798375772877 |
| Lot numbers | F40062, F40064, F40072, F40074, F40101, F40116 |
| Model numbers | 73135 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1248-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.