Device recall
Z-0850-2015: Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic…
FDA device recall · Class III · Illumina Inc
Key facts
| Recall number (Z-number) | Z-0850-2015 |
|---|---|
| Recall event | 69715 |
| Product | Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform. |
| Product code | PFS |
| Recalling firm | Illumina Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 17, 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