# FDA recall Z-1426-2024

> **Life Technologies Corporation** · Class II · device recall initiated 2024-02-07.

## 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

- **Recall number:** Z-1426-2024
- **Recalling firm:** Life Technologies Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-07
- **Report date:** 2024-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Frederick, MD, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1426-2024. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-1426-2024. Source: US FDA. Licensed CC0.

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