FDAFDA · Food and drugs·Recall number Z-0837-2024
Terragene Bionova PCD (PCD222-C)
Published February 7, 2024 · Recall initiated: December 7, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- TERRAGENE S.A.
- Distributor
- U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.
- Lot
- Product Number: Terragene Bionova PCD (PCD222-C) UDI-DI code: 07798164676027 Serial Numbers: F20002 F20021 F20046
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Argentina
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