Home / Recalls / Medical Devices
Life Technologies Corporation recalls Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(2
Recalled April 11, 2018 · FDA recall Z-1279-2018 · Life Technologies
Hazard
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 Class II
Units
9
Sold at
US Distribution to the states of: AZ, CA, NC, TX, and VA.
Description
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.
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.
Manufacturer(s)
Life Technologies Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →