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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79437

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 04, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Life Technologies Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1279-2018
Recall number
Z-1279-2018
Initiated
December 04, 2017
Classification
Class II
Status
Terminated
Quantity
9

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

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.

Code information

Lot Numbers: v1.8 (Rev. C) (REVC20170906) and v1.8 (Rev. C) (REVC27JUN2017) UDI: (01)10190302006071

Distribution pattern

US Distribution to the states of: AZ, CA, NC, TX, and VA.