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.
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.
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.
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.
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.
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).
Look for the model number A32461 on the User Guides and Assay Definition Files.
The test may report erroneous results when used on samples other than non-small cell lung cancer (NSCLC) tumors.
The recall does not specify a remedy, so check with Life Technologies for guidance.
Yes, the test is intended for use with NSCLC samples and is safe when used correctly.
We’ve drafted a message you can send Life Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-1279-2018 — Life Technologies Life Technologies Hello, I own a Life Technologies that is covered by recall Z-1279-2018 from Life Technologies. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
