Device recall
Z-1909-2016: CytoScan Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash…
FDA device recall · Class III · Affymetrix Inc
Key facts
| Recall number (Z-number) | Z-1909-2016 |
|---|---|
| Recall event | 73979 |
| Product | CytoScan Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software: MOD R LA, CytoScan Dx Pre-PCR (-20C) MOD T E W… |
| Product code | PFX |
| Recalling firm | Affymetrix Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 17, 2016 |
| 510(k) numbers | K130313 |
| FEI number | 3008715426 |
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