FDA Enforcement
Class II
Ongoing
Terragene Bionova PCD (PCD222-C)
Recall: Z-0837-2024
·
Reported February 7, 2024
Enforcement
- Recall Number
- Z-0837-2024
- Event ID
- 93625
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- TERRAGENE S.A.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 7, 2024
- Initiation Date
- December 7, 2023
- Classification Date
- January 26, 2024
- Address
- Ruta Nacional N 9, Km 280, Cp 2130, Parque Industrial Micropi, Alvear, N/A, Argentina
Description
Terragene Bionova PCD (PCD222-C)
Reason
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Code Info
Product Number: Terragene Bionova PCD (PCD222-C) UDI-DI code: 07798164676027 Serial Numbers: F20002 F20021 F20046
Distribution
U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.
Quantity
80 stripes