Device recall
Z-2611-2014: Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina…
FDA device recall · Class II · Illumina Inc
Key facts
| Recall number (Z-number) | Z-2611-2014 |
|---|---|
| Recall event | 68959 |
| 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… |
| Product code | PFF |
| Recalling firm | Illumina Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 12, 2014 |
| 510(k) numbers | K123989 |
| FEI number | 3003218906 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database