BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1279-2018 · Initiated December 4, 2017

    Recall

    Recall Number
    Z-1279-2018
    Event Number
    79437
    Firm
    Life Technologies Corporation
    FEI Number
    3003335080
    Product Code
    PQP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 4, 2017
    Terminated
    November 10, 2020
    Address
    7335 Executive Way, Frederick, MD, 21704-8354

    Description

    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.

    Reason

    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.

    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.

    Distribution

    US Distribution to the states of: AZ, CA, NC, TX, and VA.

    Quantity

    9