FDA Device recall Z-1279-2018
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461
- FDA Device
- Class II
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class II recall of Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461 by Life Technologies, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1279-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-04 |
| Published | 2018-04-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Life Technologies |
| Distribution | AZ, CA, NC, TX, VA |
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.
Identifiers
| code_info | Lot Numbers: v1.8 (Rev. C) (REVC20170906) and v1.8 (Rev. C) (REVC27JUN2017) UDI: (01)10190302006071 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1279-2018%22
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