29

Mar

2024

FDA Recall: Software Vulnerability

0

Company: Life Technologies Corporation
Date of Enforcement Report: 3/29/2024
Class II

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

Recall Number:

Z-1426-2024

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.

RECALLING FIRM/MANUFACTURER:

Life Technologies Corporation

VOLUME OF PRODUCT IN COMMERCE:

28 units

DISTRIBUTION:

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

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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