Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5

FDA device recall Z-0884-2026 · posted 2025-12-04 · Open, Classified

Recall details

Recalling firm

Illumina, Inc.

Reason for recall

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.

Action taken

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

Root cause

Vendor change control

Status

Open, Classified

Product code

PFT

Quantity affected

11916

Distribution

Worldwide - US Nationwide distribution in the states of PA, NJ, CA, NC, UT, IL, MD, NY, VA, WV, SD, TX, AL, SC, TN, KY, MI and the countries of DK, SA, FR, DE, IT, CN, PL, GB, TH, GR, VN, BE, ES, IL,

Date initiated

2025-10-28

Date posted

2025-12-04

Location

San Diego, CA