Class 3 Device Recall Agilent Resolution ctDx FIRST Sample Collection Kit

• Date Initiated by Firm: February 17, 2023
• Date Posted: April 11, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1358-2023
• Recall Event ID: 91863
• PMA Number: P210040 P210040/A005 P210040/A006
• Product Classification: Next generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
• Product: Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
• Code Information: Model/Part Number: 50032 UDI Code: N/A, single site PMA Lot Numbers: 23-0139 23-0140 23-0142 23-0143 23-0159
• Recalling Firm/ Manufacturer: AGILENT TECHNOLOGIES INC./US; 550 Kirkland Way, Suite; Kirkland WA 98033
• For Additional Information Contact: Sarah Litton; 669-255-7696
• Manufacturer Reason for Recall: Distributed sample collection kit with an unapproved instruction for use.
• FDA Determined Cause: Labeling Change Control
• Action: On 02/17/2023, the firm verbally notified its customers that as part of their post-approval commitments to FDA, a final version of the product labeling was submitted to FDA on 01/17/2023. Upon FDA's review of the final label version, FDA deemed the Instruction For Use changes to be significant, such as, changes to allow use of an alternate form to document patient information and modified shipping instructions. On or about 03/23/2023, a formal updated "URGENT: Medical Device Recall" letter will be communicated to customer providing them with the recall details. Customers are instructed to: 1. Stop use of Sample Collection Kits and place under quarantine (see Table 1 for affected product and lot numbers). 2. Complete the following four (4) records and return them to Resolution s Quality Team at qa.pdl-resolution@agilent.com: i. Attachment 1, Recall Acknowledgement and Customer Return Form: Confirm that you have received this notification by returning enclosed acknowledgement form within 3 business days of receipt, answering the questions, documenting the inventory quantities, and completing the acknowledgement box. ii. Prepare the inventory for return according to provided instructions in Attachment 2, Shipping Instructions iii. Attachment 3, Product Return - Shipping Record: For each lot number and Quest Hub location, record the number of unused products being returned, shipped by and date, shipping tracking number, scan attachment 3 and email to qa.pdl-resolution@agilent.com, include attachment 3 with the shipment. iv. Attachment 4, Certification of Product Destruction Record: If there are any devices that were opened or in the process of being used please document their destruction in this attachment, scan and return via email to qa.pdl-resolution@agilent.com. Destroy devices following your laboratory procedures as deemed appropriate by your company. For questions, contact Agilent Corporate Communications at 669-225-7696 or via emails at sarah.litton@agilent.co
• Quantity in Commerce: 560 kits
• Distribution: U.S. Nationwide distribution in the states of CA, GA, IN, NJ, and TX. O.U.S.: None
• 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.

• PMA Database: PMAs with Product Code = PQP and Original Applicant = Exact Sciences Corporation