Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Oncomine Dx Target Test User Guides and Assay Definition File Recalled by Life Technologies Corporation Due to The Oncomine Dx Target Test may report erroneous...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Life Technologies Corporation directly.
Affected Products
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.
Quantity: 9
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 5 states: AZ, CA, NC, TX, VA
About Life Technologies Corporation
Life Technologies Corporation has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report