FDA recall Z-1426-2024

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 Instrument System is not intended for whole genome or de novo sequencing Product Name Installer /SKU /Updater SKU: (1) Torrent Suite Dx Software 5.14 -A52422/ A52417 (2) Torrent Suite Dx Software 5.12.5- A46166/ A46167 (3)Torrent Suite Dx Software 5.8- A36601/ A36602 (4)Torrent Suite Dx Software 5.6.4- A33178/ A33178 (5)Torrent Suite Dx Software 5.0- A29166/ A29166

Reason for recall

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

Distribution

US Nationwide distribution in the states of CA, IN, NC OR, TN.

Key facts

Status

Ongoing

Initiation date

2024-02-07

Report date

2024-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Frederick, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1426-2024