Oncomine Dx Target Test User Guides and Assay Definition… recallZ-1279-2018 · Life Technologies Corporation · initiated Dec 4, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Life Technologies Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Device Design
What the company is doing
The following actions are described in the consignee later: Review your testing results from the Oncomine Dx Target Test to ensure that none of the reports containing BRAF V600E positive samples are impacted. Utilize Figure 1 and 2 to aid in identifying this discrepancy. If you have any questions, please contact 408.802.2341.
Recall details
- Recall number
- Z-1279-2018
- Status
- Terminated
- Initiated by the company
- Dec 4, 2017
- Recalling firm
- Life Technologies Corporation
- Quantity
- 9
- Product code
- PQP
- FDA submissions
- P160045
- Distribution
- US Distribution to the states of: AZ, CA, NC, TX, and VA.
Product description
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 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.
Code information (models, lots, serial numbers)
Lot Numbers: v1.8 (Rev. C) (REVC20170906) and v1.8 (Rev. C) (REVC27JUN2017) UDI: (01)10190302006071
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Oncomine™ Dx Target Test User Guides and Assay Definition File A32461Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system1 recall0 reports
Other devices under the same FDA submission
5 devices cleared under P160045 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Oncomine™ Dx Target Test A32441Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system1 recall1 report
- Oncomine™ Dx Target RNA Control Kit A32443Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system1 recall0 reports
- Oncomine™ Dx Target DNA Control Kit A32442Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system1 recall0 reports
- Ion Torrent™ Dx No Template Control Kit A32444Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system1 recall0 reports
- Oncomine™ Dx Target Test A32441Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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