FDA Medical Device Recalls (openFDA)
Illumina Inc: 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.
- Recall number
- Z-2611-2014
- Recalling firm
- Illumina Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2014-07-28
- Posted
- 2014-09-09
- Terminated
- 2014-11-12
- Reason
- A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended
- Root cause
- Device Design
- 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 techsupport@illumina.com.
- Quantity
- 35
- Distribution
- Worldwide Distribution - US (nationwide) and the countries of: France, Germany, Italy, Norway, UK and United Arab Emirates.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PFF
- Firm FEI
- 3003218906
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28