Reported Apr 11, 2018 · Terminated
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI:…
Life Technologies Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Life Technologies Corporation · 7335 Executive Way · Frederick, MD · 21704-8354
Is this the product you have?
- Oncomine Dx Target Test User Guides and Assay Definition File
- ModelA32461
- 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 detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling
- Lot codes and dates
- Lot Numbersv1.8 (Rev. C) (REVC20170906) and v1.8 (Rev
- C) (REVC27JUN2017) UDI(01)10190302006071
- Amount recalled
- 9
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Life Technologies Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.