Recall Z-0068-2027 ยท PFF High Throughput Dna Sequence Analyzer
Illumina, Inc.
NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
| Date | Oct 1, 2026 (initiated Sep 17, 2024) |
| Status | Open, Classified |
| Reason | Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server with a security vulnerability. |
| Root cause | Software design |
| Action | On 9/17/2024, and 1/16/2025 field safety notices were emailed to customers who were asked to take actions on webpage: https://support.illumina.com/support-content/bmc.html Customers were also asked to complete and return the Verification Form via email to techsupport@illumina.com This email can also be used to ask questions or to report potentially compromised servers. |
| Quantity | 80 |
| Distribution | Worldwide - US Nationwide distribution in the states of TX, KS, NC, CA, UT, KA, MA, NJ, MD and the countries of Spain, South Korea, Japan, Australia, Italy, United Arab Emirates, Sweden, United Kingdom, Czech Republic, Singapore, Austria, Poland, France, Germany, Finland, Switzerland, Slovakia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.