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Terragene Bionova PCD (PCD222-C)

FDA Recall #Z-0837-2024 — Class II — December 7, 2023

Recall #Z-0837-2024 Date: December 7, 2023 Classification: Class II Status: Ongoing

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.

Recalling Firm

TERRAGENE S.A. — Alvear

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

80 stripes

Distribution

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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