Oncomine Dx Target Test User Guides and Assay Definition File — Class II medical device recall Z-1279-2018
Terminated recall by Life Technologies Corporation, reported 2018-04-11, distributed in AZ, CA, NC, TX, VA. The Oncomine Dx Target Test may report erroneous results when used off-label for samples other than non-small
| Recall number | Z-1279-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Life Technologies Corporation, Frederick, MD, United States |
| Recall initiated | 2017-12-04 |
| Classified | 2018-03-30 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2020-11-10 |
| Distributed | AZ, CA, NC, TX, VA |
| Quantity | 9 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10190302006071 |
| Lot numbers | V1.8 |
| Model numbers | A32461 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1279-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.