Z-0211-2027 Class II Ongoing
FDA device recall Z-0211-2027 was initiated by Life Technologies Holdings Pte Ltd on Aug 14, 2026 and is designated Class II. Reason for recall: DNA or RNA sequencing system software has vulnerabilities. The recall status is ongoing. Affected quantity: 16.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 28, 2026
- Initiation Date
- Aug 14, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
Product Description
Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer
Reason for Recall
DNA or RNA sequencing system software has vulnerabilities.
Distribution Pattern
US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0211-2027
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026