Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1279-2018 — 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

U.S. FDA — Device Enforcement · United States · 2017-12-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1279-2018
Date of alert: 2017-12-04
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Life Technologies Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10190302006071

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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