Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted
Summary
The FDA issued a Class II for Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion by Life Technologies Corporation. 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.
Details
Source
Device Recall
External ID
Z-1426-2024
Action Date
2024-04-10
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: UDI: 10190302017848;10190302016810 Torrent Suite Dx Software versions 5.14 and earlier
Quantity Affected: 28 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-07
Company
Frederick, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Life Technologies Corporation has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Life Technologies Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Life Technologies Corporation have FDA actions?
Life Technologies Corporation has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1426-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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