Medical Device Recall: 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
TERRAGENE S.A. · December 7, 2023
Reason for Recall
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Product Description
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)
Distribution
U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.
States Affected
NATIONWIDE
Quantity Affected
36,857 strips
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0836-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.