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TERRAGENE S.A. recalls Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] T
Recalled February 7, 2024 · FDA recall Z-0836-2024 · TERRAGENE S.A
Hazard
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products. · FDA Class II
Units
36,857 strips
Sold at
U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.
Description
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Product
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)
Manufacturer(s)
TERRAGENE S.A.
Made in
Argentina
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →