Z-0837-2024 Class II Ongoing
FDA device recall Z-0837-2024 was initiated by TERRAGENE S.A. on December 7, 2023 and is designated Class II. Reason for recall: Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products. The recall status is ongoing. Affected quantity: 80 stripes.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2024
- Initiation Date
- December 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 stripes
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.
Distribution Pattern
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