Oncomine Dx Target Test recallZ-1480-2018 · Life Technologies Corporation · initiated Feb 8, 2018
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 lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
FDA root cause category: Process control
What the company is doing
The firm issued an Urgent: Medical Device Recall Notification, dated February 16, 2018, via e-mail and phone call to affected consignees. The letter identified the affected device and advised customers of the potential "No Call" or false positive outcomes. Users were advised that they may need an alternate method to determine the presence of ROS1 variant in previously tested patient samples, and that any future tests using the affected lot cannot be considered valid if "No Call" or "Negative" is the result. Requested action included reviewing previous results which used the affected lot. Customers are to complete the Customer Response Sheet provided and e-mail a scanned copy along with the letter to [email protected]. Questions and comments should be directed to Vineet Bansal, 408-802-2341, [email protected].
Recall details
- Recall number
- Z-1480-2018
- Status
- Terminated
- Initiated by the company
- Feb 8, 2018
- Recalling firm
- Life Technologies Corporation
- Quantity
- 30
- Product code
- PQP
- FDA submissions
- P160045
- Distribution
- Distributed to states: AZ, CA, NC, TX, and VA.
Product description
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
Code information (models, lots, serial numbers)
Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441
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 A32441Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system1 recall1 report
Product lines
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 RNA Control Kit A32443Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system1 recall0 reports
- 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
- 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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