Z-1279-2018Class II

Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI...

Name: Z-1279-2018 Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI...
Creator: Life Technologies Corporation
Published: 2017-12-04
License: https://open.fda.gov/license/

Life Technologies Corporation / initiated 2017-12-04 / Terminated / root cause: design

FDA source

Life Technologies Corporation began a recall of 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... on 2017-12-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1279-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-04
Posted: 2018-03-30
Terminated: 2020-11-10
Recalling firm: Life Technologies Corporation
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 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.
Product code: PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 9
Distribution: US Distribution to the states of: AZ, CA, NC, TX, and VA.
Product codes and lots: Lot Numbers: v1.8 (Rev. C) (REVC20170906) and v1.8 (Rev. C) (REVC27JUN2017) UDI: (01)10190302006071

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1279-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1279-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-03-30

Product code PQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)