TERRAGENE S.A Recalls
3 recalls on record · February 7, 2024 to March 5, 2025 · Medical Devices
Recalls by year
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 5, 2025Medical DevicesFDA
TERRAGENE S.A. recalls ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Hazard: Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
February 7, 2024Medical DevicesFDA
TERRAGENE S.A. recalls Terragene Bionova PCD (PCD222-C)
Hazard: Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
February 7, 2024Medical DevicesFDA
TERRAGENE S.A. recalls Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] T
Hazard: Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.