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
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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
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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 |
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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.
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PMA Database | PMAs with Product Code = PQP
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