# FDA recall Z-1279-2018

> **Life Technologies Corporation** · Class II · device recall initiated 2017-12-04.

## 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 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1279-2018
- **Recalling firm:** Life Technologies Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-04
- **Report date:** 2018-04-11
- **Termination date:** 2020-11-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Frederick, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1279-2018

## Citation

> AI Analytics. FDA recall Z-1279-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1279-2018. Source: US FDA. Licensed CC0.

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