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Terminated

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.

FDA Recall Z-2611-2014 · Posted 2014-09-09

Recalling FirmIllumina Inc
Recall StatusTerminated
Product CodePFF
Date Initiated2014-07-28
Date Terminated2014-11-12
Product Quantity35

Reason for Recall

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

Firm Action

Illumina notified affected customers via phone, email and Product Quality Notification letter dated July 28, 2014 to describe the software anomaly. The letter identified the affected product, problem and actions to be taken. For questions contact your local support team or Illumina Technical Support at [email protected].

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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