Recall Z-1426-2024 ยท PFF High Throughput Dna Sequence Analyzer
Life Technologies Corporation
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 Instrument System is not intended for whole genome or de novo sequencing Product Name Installer /SKU /Updat
| Date | Mar 29, 2024 (initiated Feb 7, 2024) |
| Status | Open, Classified |
| Reason | Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow them to alter settings, configurations, software, or data on the instrument |
| Root cause | Software design |
| Action | Thermo Fisher issued a Medical Device Advisory Notice on Feb 7 2024 to US Customers. Letter includes instructions for mitigation of the vulnerabilities,health risk and action to take: Therefore, Thermo Fisher Scientific advises customers using impacted versions of Torrent Suite Dx to disconnect the Ion PGM Dx sequencer, Ion OneTouch instrument and the Ion PGM" Torrent Server from the customer's network to mitigate the vulnerabilities. To access the data results generated on the instrument, Thermo Fisher Scientific recommends connecting the Ion OneTouch instrument and the Ion PGM Dx Sequencer |
| Quantity | 28 units |
| Distribution | US Nationwide distribution in the states of CA, IN, NC OR, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.