Device recall
Z-1426-2024: Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion…
FDA device recall · Class II · Life Technologies Corporation
Key facts
| Recall number (Z-number) | Z-1426-2024 |
|---|---|
| Recall event | 94122 |
| Product | Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The Ion PGM Dx… |
| Product code | PFF |
| Recalling firm | Life Technologies Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 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