Alvear, Argentina
TERRAGENE S.A. recalls
2 recalls recorded since 2018, most recently on 15 January 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 15 January 2025
- 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.
- Distribution
- US Nationwide distribution in the states of CA and KY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1248-2025
- ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Ongoing Class II Medical devices
- Recall started
- 7 December 2023
- Reason
- Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
- Distribution
- U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0837-2024, Z-0836-2024
- Terragene Bionova PCD (PCD222-C)
- Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.