Illumina, Inc. recalls Reagent Kits/ containing flow cells

An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.

On 10/28/2025, recall notices were emailed to customers who were asked to do the following: Dispose of reagents per local regulations. See Instrument Reference Guide: https://support.illumina.com/downloads/nextseq-550dx-instrument-reference-guide-1000000009513.html Illumina requests that this notice be communicated to all relevant personnel within your organization and to any external organization that has received the potentially affected reagent kits. If you experienced a run failure in a previous run using an affected flow cell, or experience leaking issues please contact Illumina Technical Support at techsupport@illumina.com Complete and return the verification form via email to techsupport@illumina.com

• FDA enforcement recordOfficial FDA database entry for Z-0884-2026
• FDA device classification · PFTOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.3800The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Illumina, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.