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.
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.
The test may produce a false negative result for ROS1 fusion, a specific cancer biomarker. If a doctor relies on this false negative, they might incorrectly stop using crizotinib, a targeted cancer drug, leading to treatment gaps.
Patients undergoing cancer testing who use these specific diagnostic tests may be affected. Physicians ordering the tests are most at risk of making treatment errors.
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.
Look for model numbers A32441 or A32451 on the test kit label.
The test may produce false negative results for ROS1 fusion, which could lead to doctors skipping a critical cancer treatment.
Check the model number on the test kit. If it's A32441 or A32451, contact Life Technologies for guidance.
The recall addresses potential treatment errors, not physical injury. The risk is low and specific to test accuracy.
We’ve drafted a message you can send Life Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-1480-2018 — Life Technologies Life Technologies Hello, I own a Life Technologies that is covered by recall Z-1480-2018 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.
