FDA-Device2024-02-07Class II
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)
TERRAGENE S.A.
Hazard
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Sold states
U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.
Affected count
36,857 strips
Manufactured in
Ruta Nacional N 9, Km 280, Cp 2130, Parque Industrial Micropi, Alvear, Argentina
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0836-2024Don't want to check this manually?
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