Class II

Medical Device Recall: Terragene Bionova PCD (PCD222-C)

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.

Distribution

U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.

States Affected

NATIONWIDE

Quantity Affected

80 stripes

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0837-2024

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.