Device recall
Z-1279-2018: Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461…
FDA device recall · Class II · Life Technologies Corporation
Key facts
| Recall number (Z-number) | Z-1279-2018 |
|---|---|
| Recall event | 79437 |
| Product | Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide… |
| Product code | PQP |
| Recalling firm | Life Technologies Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 10, 2020 |
| PMA numbers | P160045 |
| FEI number | 3003335080 |
At a glance
- None 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