CLASS II Device recall · Reported 11 Apr 2018 · FDA Enforcement Report
Oncomine Dx Target Test User Guides and Assay Definition File recalled
Life Technologies is recalling Oncomine Dx Target Test User Guides and Assay Definition File, distributed in Arizona, California, North Carolina, Texas, Virginia. The recall was initiated on 4 Dec 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1279-2018
- FDA event ID
- 79437
- Recalling firm
- Life Technologies, Frederick, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Dec 2017
- FDA classified
- 30 Mar 2018
- Reported
- 11 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 4 Dec 2017 | Recall initiated by company | |
| 30 Mar 2018 | Classified by FDA | +116 days |
| 11 Apr 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to the states of: AZ, CA, NC, TX, and VA.
ArizonaCaliforniaNorth CarolinaTexasVirginia
Stores named: Target
Questions about this recall
Is Oncomine Dx Target Test User Guides and Assay Definition File recalled?
Yes. Life Technologies recalled Oncomine Dx Target Test User Guides and Assay Definition File on 4 Dec 2017. The recall is Class II and its status is Terminated. Recall number Z-1279-2018.
Why was it 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.
Which lots are affected?
Lot Numbers: v1.8 (Rev. C) (REVC20170906) and v1.8 (Rev. C) (REVC27JUN2017) UDI: (01)10190302006071
Where was it sold?
US Distribution to the states of: AZ, CA, NC, TX, and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Life Technologies
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Torrent Suite Dx recalled by Life Technologies | Life Technologies | Device Malfunction | Nationwide |
| Device | CLASS II | The TaqPath Rt-pcr Covid-19 Kit recalled by Life Technologies | Life Technologies | Potency & Assay | 45 states |
| Device | CLASS II | The TaqPath Rt-pcr Covid-19 Kit recalled by Life Technologies | Life Technologies | Potency & Assay | 45 states |
| Device | CLASS II | Oncomine Dx Target Test RNA Control- IVD recalled by Life Technologies | Life Technologies | Other | Nationwide |
| Device | CLASS II | Ion Torrent Dx No Template Control Kit- IVD recalled | Life Technologies | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |