FDA Recalls Terragene Bionova PCD Device Due to Instructions Discrepancy
Terragene S.A. is recalling Terragene Bionova PCD (Model PCD222-C) medical devices nationwide due to a discrepancy between FDA-cleared instructions for use and the actual instructions distributed with the products.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling and documentation discrepancy. No illnesses, injuries, or hospitalizations have been reported. The hazard is a mismatch between cleared and distributed instructions for use, qualifying as a minor labeling error under the Moderate severity threshold.
Plain-English summary
Terragene S.A. is recalling the Terragene Bionova PCD (Model PCD222-C) medical device. The device was distributed nationwide in the states of Georgia, Indiana, Michigan, Montana, New York, Pennsylvania, Texas, and Virginia.
The recall was initiated due to a discrepancy between the Indications for Use (IFU) that was cleared by the FDA and the actual Indications for Use distributed with the products. This discrepancy means users may not have access to the correct instructions for proper use of the device.
Affected units are identified by Serial Numbers F20002, F20021, and F20046 (UDI-DI: 07798164676027). Consumers and healthcare providers who have received these devices should discontinue use and contact the manufacturer or their healthcare provider for guidance on obtaining the correct instructions or device replacement.
The FDA is monitoring this recall. For questions about this recall, contact Terragene S.A.
The recalled product
- Product
- Terragene Bionova PCD (PCD222-C)
- Manufacturer
- TERRAGENE S.A.
- Category
- Medical Device
- Hazard
- mis-labeling
- incorrect-instructions
Distribution
Distributed nationwide across the United States.
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