Class 2 Device Recall Oncomine Target Dx Test

• Date Initiated by Firm: March 16, 2020
• Create Date: April 14, 2020
• Recall Status: Terminated on March 26, 2021
• Recall Number: Z-1706-2020
• Recall Event ID: 85203
• PMA Number: P160045
• Product Classification: Next generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
• Product: Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441
• Code Information: Lot Codes: S119_2174743 S119_2188760 S119_2165333 P119_2149298 S217_04001 1705002 UDI: (01)10190302015103
• Recalling Firm/ Manufacturer: Life Technologies Corporation; 7335 Executive Way; Frederick MD 21704-8354
• Manufacturer Reason for Recall: Extended Expiration Date prior to clearance
• FDA Determined Cause: Incorrect or no expiration date
• Action: Thermo Fisher issued notification on 3/16/20 via email followed by hard copy on 3/18/20, stating reason for recall, health risk and action to take: Review the expiration date of the products referenced in the table included in the Customer Notification and take the following actions: "Notify all Oncomine Dx Target Test users in your facility of this issue. "Review the expiration date of the products referenced in the table above and using Attachment 1 of this letter, take the following actions. Attachment 1 provides the corrected expiration dates per lot. For products that are past the 9-month corrected expiration date per Attachment 1: Discontinue use of the product, record the kit lot numbers and quantities impacted on the attached Customer Response Sheet, and email the completed response sheet to gabriella.armin@thermofisher.com. For products that are still within the 9-month corrected expiration date per Attachment 1: Correct the expiration dating on the product labelling within your inventory by reviewing Attachment 1 to determine the correct expiration date per kit lot. Strike through the incorrect expiration date and add the new one using permanent ink or amend the label by adding an additional label correcting the expiration date on the labelling. The updated labelled product can continue to be used until the 9-month expiration date, after which any remaining product should be discarded. Note: If affected product was used past the 9-month corrected expiration date per Attachment 1, but before the 12-month expiration date on the kit labels, there is no anticipated risk of generating inaccurate/incorrect results because the system will inform the user if the assay did not meet run passing criteria and test results wont be generated. Therefore, no action on your part is required. If you have any technical questions or concerns, please contact Technical Support at [NA --800-955-6288 option 4 or techsupport@thermofisher.com]
• Quantity in Commerce: 35 units
• Distribution: US Nationwide distribution.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = PQP