# FDA recall Z-1248-2025

> **TERRAGENE S.A.** · Class II · device recall initiated 2025-01-15.

## 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.

## Distribution

US Nationwide distribution in the states of CA and KY.

## Key facts

- **Recall number:** Z-1248-2025
- **Recalling firm:** TERRAGENE S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-15
- **Report date:** 2025-03-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alvear, N/A, Argentina

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1248-2025

## Citation

> AI Analytics. FDA recall Z-1248-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1248-2025. Source: US FDA. Licensed CC0.

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