TERRAGENE S.A.: Medical Device Recall in 2024 - (Recall #: Z-0837-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Terragene Bionova PCD (PCD222-C)

Product Classification:

Class II

Date Initiated: December 7, 2023

Date Posted: February 7, 2024

Recall Number: Z-0837-2024

Event ID: 93625

Reason for Recall:

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

Status: Ongoing

Product Quantity: 80 stripes

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated