Device product
Terragene Bionova PCD (PCD222-C)
Z-0837-2024
Product summary
- Firm
- TERRAGENE S.A.
- Event
- Event 93625
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 80 stripes
- Official record key
device-enforcement:Z-0837-2024
Official wording
Reason: Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
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.
Derived failure modes
-
Unknown
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.