Class 2 Device Recall Oncomine Dx Target Test

• Date Initiated by Firm: February 08, 2018
• Create Date: April 20, 2018
• Recall Status: Terminated on May 12, 2020
• Recall Number: Z-1480-2018
• Recall Event ID: 79649
• PMA Number: P160045
• Product Classification: Next generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
• Product: Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
• Code Information: Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441
• FEI Number: 3003335080
• Recalling Firm/ Manufacturer: Life Technologies Corporation; 7335 Executive Way; Frederick MD 21704-8354
• Manufacturer Reason for Recall: The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
• FDA Determined Cause: Process control
• Action: The firm issued an Urgent: Medical Device Recall Notification, dated February 16, 2018, via e-mail and phone call to affected consignees. The letter identified the affected device and advised customers of the potential "No Call" or false positive outcomes. Users were advised that they may need an alternate method to determine the presence of ROS1 variant in previously tested patient samples, and that any future tests using the affected lot cannot be considered valid if "No Call" or "Negative" is the result. Requested action included reviewing previous results which used the affected lot. Customers are to complete the Customer Response Sheet provided and e-mail a scanned copy along with the letter to vineet.bansal1@thermofisher.com. Questions and comments should be directed to Vineet Bansal, 408-802-2341, vineet.bansal1@thermofisher.com.
• Quantity in Commerce: 30
• Distribution: Distributed to states: AZ, CA, NC, 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = PQP