FDAFDA · Food and drugs·Recall number Z-1426-2024
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
Published April 10, 2024 · Recall initiated: February 7, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Life Technologies Corporation
- Distributor
- US Nationwide distribution in the states of CA, IN, NC OR, TN.
- Lot
- UDI: 10190302017848;10190302016810 Torrent Suite Dx Software versions 5.14 and earlier
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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