Home / Recalls / TERRAGENE S.A. / Z-0837-2024

Z-0837-2024 Class II Ongoing

Recalled by TERRAGENE S.A. — Alvear

Recall Details

Product Type: Devices
Report Date: February 7, 2024
Initiation Date: December 7, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 80 stripes

Product Description

Terragene Bionova PCD (PCD222-C)

Reason for Recall

Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

Distribution Pattern

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

Code Information

Product Number: Terragene Bionova PCD (PCD222-C) UDI-DI code: 07798164676027 Serial Numbers: F20002 F20021 F20046