Terragene S.A. FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.Class IIJan 15, 2025Error in the IFU lists an incorrect incubation time on one o	Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incu	Class IIDevices	Jan 15, 2025
Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] TClass IIDec 7, 2023Due to a discrepancy between the FDA-Cleared Indications for	Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the	Class IIDevices	Dec 7, 2023
Terragene Bionova PCD (PCD222-C)Class IIDec 7, 2023Due to a discrepancy between the FDA-Cleared Indications for	Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the	Class IIDevices	Dec 7, 2023