FDA Medical devices recall ·
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device recall
- Recall number
- Z-1248-2025
- Date
- (initiated January 15, 2025)
- Company / brand
- Terragene S.A.
Ruta Nacional N 9, Km 280, Cp 2130, Alvear, N/A, Argentina - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 914 devices in the U.S.
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.
Distribution
US Nationwide distribution in the states of CA and KY.
States: California Kentucky
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1248-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.