Ion Torrent Genexus Dx Software Recalled for Security Vulnerabilities
Life Technologies is recalling 16 Ion Torrent Genexus Dx systems due to software vulnerabilities. The affected units are distributed in 11 US states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II due to software vulnerabilities in a medical device. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Life Technologies Holdings Pte Ltd is recalling 16 units of the Ion Torrent Genexus Dx with software, Catalog A40003539. The recall is due to vulnerabilities in the software that supports the Ion Torrent Genexus Dx Integrated Sequencer.
The affected software version is 6.8.2.1 and earlier. The recall covers units distributed in Pennsylvania, North Carolina, Colorado, California, Louisiana, Kentucky, New York, Arizona, Massachusetts, and Oklahoma. Specific serial numbers and UDI-DI codes are listed in the official recall notice.
The source text does not provide specific instructions for consumers or healthcare providers on how to address the vulnerabilities, nor does it report any illnesses, injuries, or deaths associated with the use of the affected devices.
The recalled product
- Product
- Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer
- Manufacturer
- Life Technologies Holdings Pte Ltd
- Hazard
- Affected units
- 16
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- UDI-DI: 10190302018883
- 2619726010247
- 2619124060941
- 2619124060942
- 2619725090229
- 2619725100238
- 2619122070666
- 2619725080220
- 2619725090226
- 2619726010251
- 2619726020265
- 2619725090225
- 2619725100235
- 2619725050205
- 2619726010249
- 2619122070658
Distribution
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