Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0837-2024·Announced 2024-02-07

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Affected units: 80

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 2 recalled by TERRAGENE S.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · TERRAGENE S.A.

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