Oncomine Dx Target Test — Class II medical device recall Z-1480-2018
Terminated recall by Life Technologies Corporation, reported 2018-05-02, distributed in AZ, CA, NC, TX, VA. The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fus
| Recall number | Z-1480-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Life Technologies Corporation, Frederick, MD, United States |
| Recall initiated | 2018-02-08 |
| Classified | 2018-04-20 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2020-05-12 |
| Distributed | AZ, CA, NC, TX, VA |
| Quantity | 30 |
| UPC / GTIN / UDI-DI | 10190302006385 |
| Lot numbers | 1705001 |
| Model numbers | A32441, A32451 |
Product
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1480-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.