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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68959

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

Open FDA event record

Event summary

Timeline bucket
July 28, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Illumina Inc

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

Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.

Z-2611-2014
Recall number
Z-2611-2014
Initiated
July 28, 2014
Classification
Class II
Status
Terminated
Recalling firm
Illumina Inc
Quantity
35

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended

Code information

M70113 M70144 M70131 M70138 M70143 M70119 M70134 M70156 M70103 M70123 M70159 M70153 M70136 M70102 M70137 M70130 M00533L M70139 M70132 M70160 M70106 M70135 M70107 M70104 M70108 M70157 M70105 M70165 M70116 M70172 M70166 M70114 M70158 M70109 M70115

Distribution pattern

Worldwide Distribution - US (nationwide) and the countries of: France, Germany, Italy, Norway, UK and United Arab Emirates.