Recall Z-1279-2018— Life Technologies Corporation

Class II FDA medical device recall by Life Technologies Corporation, initiated 2017-12-04, terminated 2020-11-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..

Recalling firm

Life Technologies Corporation

Classification

Class II

Status

Terminated

Initiated

2017-12-04

Terminated

2020-11-10

Firm location

Frederick, MD, United States

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