Recall Z-2611-2014 ยท PFF High Throughput Dna Sequence Analyzer
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
| Date | Sep 9, 2014 (initiated Jul 28, 2014) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.