Terragene Bionova PCD (Unknown) – Instructions for Use Discrepancy (2023)
Discrepancy in product instructions may mislead users about device capabilities.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terragene Bionova PCD (PCD222-C)
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Product Number: Terragene Bionova PCD (PCD222-C) UDI-DI code: 07798164676027 Serial Numbers: F20002 F20021 F20046
A medical device manufacturer is recalling Terragene Bionova PCD (PCD222-C) due to Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Recommended Action
Per FDA guidance
On 12/07/2023, the firm notified via email its initial importers/distributor a "Voluntary Recall Notification " that contained a "COMMUNICATION TO CUSTOMER VOLUNTARY RECALL OF PRODUCT/URGENT: MEDICAL DEVICE RECALL" Letter informing them of the discrepancies identified in the IFUs of some products that mentions extended cycles that may mislead users to think that these cycles are part of the FDA-cleared indications for use of the product. Initial Importers/Distributors are instructed to send the following information to Terragene: -Quantity in stock -Quantity distributed -Consignees On or about 12/22/2023, the firm initiated distribution, via email, an "URGENT: MEDICAL DEVICE RECALL" Letter to customers (identified by their Initial Imports/Distributors) informing them of the Recall issue (discrepancy identified in the IFU) provide an updated IFU (version 4) correcting the issue. Customers are instructed to print the updated IFU and attach it to their remaining inventory, and to discard the older IFU versions (version 1 thru 3). For questions or concerns, contact customer.service@terragene.com or www.terragene.com , or +1-844-837-7243 Monday thru Friday 6:00 AM to 3:00 PM, Eastern Time.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026