Torrent Suite Dx Software versions affected by cybersecurity vulnerability
Life Technologies Corporation is recalling Torrent Suite Dx Software versions 5.14 and earlier due to a cybersecurity vulnerability that could allow unauthorized access to alter instrument settings, configurations, software, or data.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving a cybersecurity vulnerability that could compromise the integrity of diagnostic data and instrument operation. No illnesses, injuries, or confirmed exploitation have been reported, placing this in the risk-of-harm category without reported harm.
Plain-English summary
Life Technologies Corporation is recalling Torrent Suite Dx Software versions 5.14 and earlier, which are used with Ion PGM DX Systems for targeted sequencing of human genomic DNA (gDNA) from whole-blood and formalin-fixed, paraffin-embedded (FFPE) tissue samples.
The FDA classified this recall as Class II. The software contains a cybersecurity vulnerability that could allow an unauthorized threat actor to access the instrument and alter its settings, configurations, software, or data.
Approximately 28 units have been distributed across the United States, including California, Indiana, North Carolina, Oregon, and Tennessee. The affected software versions are 5.14, 5.12.5, 5.8, 5.6.4, and 5.0.
Users should contact Life Technologies Corporation for instructions on updating their software to a patched version. The FDA has assigned recall number Z-1426-2024 to this recall.
The recalled product
- 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
- Manufacturer
- Life Technologies Corporation
- Hazard
- software-vulnerability
- data-integrity
- unauthorized-access
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 10190302017848
- 10190302016810 Torrent Suite Dx Software versions 5.14 and earlier
Distribution
Distributed nationwide across the United States.
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