| | Class 2 Device Recall ION TORRENT" GENEXUS" DX SOFTWARE 6.8.2.1 AND EARLIER |  |
| Date Initiated by Firm | August 14, 2026 |
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| Date Posted | October 22, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0211-2027 |
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| Recall Event ID |
99885 |
| Product Classification |
High throughput DNA sequence analyzer - Product Code PFF
|
| Product | Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer |
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| Code Information |
UDI-DI: 10190302018883, Software: 6.8.2.1 and earlier.
Sequencer UDI-DI: 10190302017794.
Sequencer Serial Numbers:
2619124040913,
2619726010247,
2619124060941,
2619124060942,
2619725090229,
2619725100238,
2619122070666,
2619725080220,
2619725090226,
2619726010251,
2619726020265,
2619725090225,
2619725100235,
2619725050205,
2619726010249,
2619122070658 |
| FEI Number |
3003673482
|
Recalling Firm/
Manufacturer |
Life Technologies Holdings Pte Ltd
Blk 33 Marsiling Ind Estate Road 3
#07-06
Singapore
Singapore
|
| For Additional Information Contact |
6362-9300 |
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Manufacturer Reason
for Recall | DNA or RNA sequencing system software has vulnerabilities. |
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FDA Determined
Cause 2 | Software design |
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| Action | On 8/14/2026, recall notices were emailed to customers who were informed of the following:
Once the software becomes available, your field support specialist or your local Service and Support representative will reach out to schedule a software upgrade.
Firm recommends that customers back up their data before any software upgrades. Please refer to "Manage backup settings and restore runs (administrator)" section of the user guide.
Complete and return the CUSTOMER RESPONSE Acknowledgement and Receipt Form via email to genexusdx.notifications@thermofisher.com; and also contact the firm at this email address is you have any technical questions or concerns. |
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| Quantity in Commerce | 16 |
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| Distribution | US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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