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U.S. Department of Health and Human Services

Class 2 Device Recall Terragene Bionova PCD (PCD222C)

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  Class 2 Device Recall Terragene Bionova PCD (PCD222C) see related information
Date Initiated by Firm December 07, 2023
Date Posted January 26, 2024
Recall Status1 Open3, Classified
Recall Number Z-0837-2024
Recall Event ID 93625
510(K)Number K163646  
Product Classification Indicator, biological sterilization process - Product Code FRC
Product Terragene Bionova PCD (PCD222-C)
Code Information Product Number: Terragene Bionova PCD (PCD222-C) UDI-DI code: 07798164676027 Serial Numbers: F20002 F20021 F20046
Recalling Firm/
Manufacturer		 TERRAGENE S.A.
Ruta Nacional N 9, Km 280, Cp 2130
Parque Industrial Micropi
Alvear Argentina
For Additional Information Contact Customer Service
844-8377243
Manufacturer Reason
for Recall		 Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
FDA Determined
Cause 2		 Labeling False and Misleading
Action 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.
Quantity in Commerce 80 stripes
Distribution U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRC and Original Applicant = Terragene SA
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