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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Life Technologies Corporation: Torrent Suite Dx Software Recalled for Cyber Vulnerability and Data Alteration

Agency Publication Date: March 29, 2024
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Summary

Life Technologies Corporation has recalled 28 units of Torrent Suite Dx Software (versions 5.14 and earlier) used with Ion PGM DX Systems. These systems are used for targeted DNA and RNA sequencing from blood and tissue samples. The recall was initiated because a vulnerability could allow an unauthorized person to access the instrument and change settings, configurations, or data. This software was distributed in California, Indiana, North Carolina, Oregon, and Tennessee.

Risk

A security vulnerability may allow a threat actor to exploit the software and alter sensitive instrument settings or genomic data. This could potentially lead to incorrect sequencing results, affecting patient diagnosis or treatment plans.

What You Should Do

  1. Identify if your laboratory is using Torrent Suite Dx Software versions 5.14, 5.12.5, 5.8, 5.6.4, or 5.0 in connection with Ion PGM DX Systems.
  2. Check your software version and UDI (Unique Device Identifier) numbers 10190302017848 or 10190302016810 to confirm if your system is affected.
  3. Review the SKU numbers for your software: Torrent Suite Dx 5.14 (A52422/A52417), 5.12.5 (A46166/A46167), 5.8 (A36601/A36602), 5.6.4 (A33178), or 5.0 (A29166).
  4. Contact Life Technologies Corporation at their Frederick, Maryland location or through your assigned technical representative to receive guidance on software updates or security patches.
  5. Consult with your healthcare provider or laboratory supervisor regarding any concerns about genomic data integrity if you believe your system has been accessed by unauthorized parties.
  6. For further information, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Technical mitigation and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Torrent Suite Dx Software 5.14
Model / REF:
A52422
A52417
Product: Torrent Suite Dx Software 5.12.5
Model / REF:
A46166
A46167
Lot Numbers:
UDI: 10190302017848
UDI: 10190302016810
Product: Torrent Suite Dx Software 5.8
Model / REF:
A36601
A36602
Product: Torrent Suite Dx Software 5.6.4
Model / REF:
A33178
Product: Torrent Suite Dx Software 5.0
Model / REF:
A29166

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94122
Status: Active
Manufacturer: Life Technologies Corporation
Sold By: Life Technologies Corporation
Manufactured In: United States
Units Affected: 28 units
Distributed To: California, Indiana, North Carolina, Oregon, Tennessee

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.