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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79649

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

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Event summary

Timeline bucket
February 08, 2018
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, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.

Z-1480-2018
Recall number
Z-1480-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Quantity
30

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441

Distribution pattern

Distributed to states: AZ, CA, NC, TX, and VA.