Device recall
Z-0849-2015: Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal…
FDA device recall · Class II · Illumina Inc
Key facts
| Recall number (Z-number) | Z-0849-2015 |
|---|---|
| Recall event | 69766 |
| Product | Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries… |
| Product code | PFS |
| Recalling firm | Illumina Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 18, 2015 |
| 510(k) numbers | K132750 |
| FEI number | 3003218906 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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