Lower riskMedical device recall · FDA · Published February 8, 2018
Life Technologies Oncomine Dx Tests Recall: False Negative Risk
Life Technologies recalls two cancer test kits due to potential false negatives in ROS1 fusion detection, which could lead to incorrect treatment decisions.
The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
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Contact the company
📍Recalling firmLife Technologies Corporation7335 Executive Way · Frederick, MD 21704-8354
✎ GovInfoNow plain-language explainer
Life Technologies is recalling two cancer diagnostic tests (Oncomine Dx Target Test and RNA/DNA Panel) because a lower RNA concentration might cause false negative results for ROS1 fusion. This could mean doctors might incorrectly skip a critical cancer treatment. Read more at govinfonow.com/recall/72016-life-technologies-oncomine-dx-tests-recall-false-negative-risk.
“Life Technologies Oncomine Dx Tests Recall: False Negative Risk.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72016-life-technologies-oncomine-dx-tests-recall-false-negative-risk. Based on FDA recall #Z-1480-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1480-2018%22&limit=1).
The FDA announced on Feb. 8, 2018, that Life Technologies Corporation voluntarily recalled Oncomine Dx Target Test and RNA/DNA Panel devices due to a hazard of false negative results for ROS1 fusion reporting. The agency issued recall number Z-1480-2018.
How to tell if you have it
Oncomine Dx Target Test, Model No. A32451
Oncomine Dx Target RNA/DNA Panel, Model No. A32441
Lot 1705001
UPC 10190302006385
The hazard
The lower concentration of the RNA panel could cause a NO CALL or false negative for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
Context
GovInfoNow's records show Life Technologies Corporation has 6 other recalls on record since Dec. 4, 2017. Other recent recalls of similar products include Torrent Suite Dx Software 5.14 (Feb. 7, 2024), COVID-19 Test Software (Aug. 6, 2020), and Oncomine RNA Control (March 16, 2020). Other recent recalls of similar products include Revogene C. difficile Test (Dec. 5, 2025), LH One Step Ovulation Test Device (Nov. 22, 2025), and Vivoo Protein Test (Nov. 22, 2025).
How to tell if you have this one
Check for model numbers A32441 (RNA/DNA Panel) or A32451 (Target Test) on the test kit. These were sold with lot number 1705001 and UDI code (01)10190302006385(17)180220(10)1705001(240)A32441.
Brand
Life Technologies
Product
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Test Model Number
Look for model numbers A32441 or A32451 on the test kit label.
Where it went and when
Where it was distributed
Distributed in 5 states.
Listed by the agency
Not listed
FDA distribution: “Distributed to states: 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 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1480-2018 (February 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1480-2018 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.