Life Technologies Oncomine Dx Test Guides May Give Wrong Results for Non-Lung Cancer
Life Technologies recalls Oncomine Dx Target Test User Guides and Assay Definition Files for non-small cell lung cancer tests. These may report incorrect results when used on samples other than NSCLC tumors.
Lower-risk 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.
Contact the company
What happened, in plain English
Life Technologies is recalling Oncomine Dx Target Test User Guides and Assay Definition Files (Model A32461) because they can give wrong results when used on samples other than non-small cell lung cancer (NSCLC) tumors. This could lead to incorrect treatment decisions for patients. Read more at govinfonow.com/recall/72400-life-technologies-oncomine-dx-test-guides-may-give-wrong-results.
Source Summary by GovInfoNow · govinfonow.com/recall/72400-life-technologies-oncomine-dx-test-guides-may-give-wrong-results · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1279-2018
Cite this page
“Life Technologies Oncomine Dx Test Guides May Give Wrong Results for Non-Lung Cancer.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72400-life-technologies-oncomine-dx-test-guides-may-give-wrong-results. Based on FDA recall #Z-1279-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1279-2018%22&limit=1).
Why it’s dangerous
The test is designed to detect genetic changes in NSCLC tumors. When used on samples from other cancer types, it may report incorrect results, potentially leading to wrong treatment choices.
Who’s affected
Patients using the Oncomine Dx Target Test for non-small cell lung cancer (NSCLC) may be affected. Doctors and labs that use the test for NSCLC samples are most at risk of incorrect results.
How to tell if you have this one
Check for the model number A32461 on the User Guides and Assay Definition Files. The product was sold with lot numbers v1.8 (Rev. C) (REVC20170906) and v1.8 (Rev. C) (REVC27JUN2017).
- Brand
Life Technologies- Product
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI- Category
Medical device
What to do — step by step
Check Product Details
Look for the model number A32461 on the User Guides and Assay Definition Files.
Where it went and when
Where it was distributed
Distributed in 5 states.
FDA distribution: “US Distribution to the states of: AZ, CA, NC, TX, and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, North Carolina, Texas, Virginia.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this test safe for NSCLC patients?
Yes, the test is intended for use with NSCLC samples and is safe when used correctly.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1279-2018 (December 4, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1279-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.