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U.S. Department of Health and Human Services

Class 2 Device Recall Oncomine Dx Target Test

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  Class 2 Device Recall Oncomine Dx Target Test see related information
Date Initiated by Firm December 04, 2017
Create Date March 30, 2018
Recall Status1 Terminated 3 on November 10, 2020
Recall Number Z-1279-2018
Recall Event ID 79437
PMA Number P160045 
Product Classification Next generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
Product Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461

The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.
Code Information Lot Numbers: v1.8 (Rev. C) (REVC20170906) and v1.8 (Rev. C) (REVC27JUN2017)  UDI: (01)10190302006071
Recalling Firm/
Manufacturer		 Life Technologies Corporation
7335 Executive Way
Frederick MD 21704-8354
For Additional Information Contact Vineet Bansal
408-802-2341
Manufacturer Reason
for Recall		 The Oncomine Dx Target Test may report erroneous results when used off-label for samples other than non-small cell lung cancer (NSCLC) tumor specimens.
FDA Determined
Cause 2		 Device Design
Action The following actions are described in the consignee later: Review your testing results from the Oncomine Dx Target Test to ensure that none of the reports containing BRAF V600E positive samples are impacted. Utilize Figure 1 and 2 to aid in identifying this discrepancy. If you have any questions, please contact 408.802.2341.
Quantity in Commerce 9
Distribution US Distribution to the states of: 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
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