FDA recall, , Moderate risk
Life Technologies Ion Torrent Genexus Dx Integrated Sequencer
The Ion Torrent Genexus Dx with software has vulnerabilities in its DNA or RNA sequencing system software.
Summary by Recall Canary from the FDA notice
What happened
Life Technologies Holdings Pte Ltd began a recall of the Ion Torrent Genexus Dx with software, Catalog: A40003539, on August 14, 2026, because the DNA or RNA sequencing system software has vulnerabilities. The FDA added the recall to its Enforcement Report on October 22, 2026. The product was distributed in Arizona, California, Colorado, Kentucky, Louisiana, Massachusetts, North Carolina, New York, Oklahoma, and Pennsylvania.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer
- UDI-DI
- 10190302018883
- 6.8.2.1
- 10190302017794
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Pennsylvania, North Carolina, Colorado, California, Louisiana, Kentucky, New York, Arizona, Massachusetts, Louisiana, Oklahoma.
- Company
- Life Technologies Holdings Pte Ltd
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99885
- Recall number
- Z-0211-2027
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary