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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.

FDA Recall Z-1279-2018 · Posted None

Recalling FirmLife Technologies Corporation
Recall StatusTerminated
Product CodePQP
Date Initiated2017-12-04
Date Terminated2020-11-10
Product Quantity9

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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