Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumin
FDA device recall Z-2611-2014 · posted 2014-09-09 · Terminated
Recall details
- Recalling firm
- Illumina Inc
- Reason for recall
- A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended
- Action taken
- 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 techsupport@illumina.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- PFF
- Quantity affected
- 35
- Distribution
- Worldwide Distribution - US (nationwide) and the countries of: France, Germany, Italy, Norway, UK and United Arab Emirates.
- Date initiated
- 2014-07-28
- Date posted
- 2014-09-09
- Date terminated
- 2014-11-12
- Location
- San Diego, CA
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