Terragene Bionova PCD (PCD222-C)

This recall is currently active, issued January 26, 2024.

Recall Initiated

December 7, 2023

Posted

January 26, 2024

Recall Number

Z-0837-2024

Quantity

80 stripes

Official Source

View on FDA website ↗

Reason for Recall

Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

Distribution

U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.

Lot / Code Info

Product Number: Terragene Bionova PCD (PCD222-C) UDI-DI code: 07798164676027 Serial Numbers: F20002 F20021 F20046

Root Cause

Labeling False and Misleading

Action Taken

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.