ClearanceBrief
Recall Z-0211-2027 ยท PFF High Throughput Dna Sequence Analyzer

Life Technologies Holdings Pte Ltd

Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer

DateOct 22, 2026 (initiated Aug 14, 2026)
StatusOpen, Classified
ReasonDNA or RNA sequencing system software has vulnerabilities.
Root causeSoftware design
ActionOn 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 thi
Quantity16
DistributionUS Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.