NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
FDA Recall Z-0068-2027 · Posted 2026-10-01
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Recalling FirmIllumina, Inc.
Recall StatusOpen, Classified
Product CodePFF
Date Initiated2024-09-17
Product Quantity80
Reason for Recall
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.
Firm 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
[email protected] This email can also be used to ask questions or to report potentially compromised servers.
Root Cause
Software design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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