Life Technologies Recalls Oncomine Dx Target Test User Guides
Life Technologies is recalling Oncomine Dx Target Test user guides and assay definition files because they may report erroneous results when used off-label for non-NSCLC samples.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may report erroneous results when used off-label, posing a risk of harm to patients through incorrect diagnostic information, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Life Technologies Corporation is recalling nine units of the Oncomine Dx Target Test User Guides and Assay Definition File, Model A32461. The affected lots are v1.8 (Rev. C) (REVC20170906) and v1.8 (Rev. C) (REVC27JUN2017). The Oncomine Dx Target Test is a qualitative in vitro diagnostic test used to detect specific genetic variants in non-small cell lung cancer (NSCLC) tumor samples.
The recall was initiated because the test may report erroneous results when used off-label for samples other than NSCLC tumor specimens. The affected products were distributed in the United States to the states of Arizona, California, North Carolina, Texas, and Virginia.
Healthcare facilities and laboratories that possess these specific user guides and assay definition files should stop using them for off-label applications. Users should contact Life Technologies Corporation for further instructions on how to proceed with the recall.
The recalled product
- 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 detec
- Manufacturer
- Life Technologies Corporation
- Hazard
- Affected units
- 9
Distribution
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