Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Oncomine Dx Target Test

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Oncomine Dx Target Test see related information
Date Initiated by Firm February 08, 2018
Create Date April 20, 2018
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = LIFE TECHNOLOGIES CORPORATION
-
-