Recall Atlas

Illumina recalls

5 official recalls and safety alerts involving Illumina since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Illumina or the relevant agency.

  1. 2026-10-07
  2. US
    Drugs & medicalClass II

    Illumina, Inc. recalls NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130

    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.

    FDA · DeviceIllumina, Inc.Worldwide - US Nationwide distribution in the states of TX, KS, NC, CA, UT,…Official notice →
  3. 2025-12-10
  4. US
    Drugs & medicalClass II

    Illumina, Inc. recalls Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD,…

    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…

    FDA · DeviceIllumina, Inc.Worldwide - US Nationwide distribution in the states of PA, NJ, CA, NC, UT,…Official notice →
  5. 2023-06-28
  6. US
    Drugs & medicalClass II

    Illumina, Inc. recalls MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.

    Cybersecurity vulnerability concerning the software used for sequencing instruments.

    FDA · DeviceIllumina, Inc.Worldwide distribution - US Nationwide and the countries of Algeria, AU…Official notice →
  7. 2022-06-22
  8. US
    Drugs & medicalClass II

    Illumina, Inc. recalls illumina Model NextSeq 550 Dx REF 20005715

    cybersecurity vulnerability

    FDA · DeviceIllumina, Inc.Worldwide distribution - U.S. Nationwide distribution including in the states…Official notice →
  9. 2022-04-06
  10. US
    Drugs & medicalClass II

    Illumina, Inc. recalls Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

    There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short…

    FDA · DeviceIllumina, Inc.US: PA, WA, CA, MI, FL, MD, AR, UT NC, Fl, IL, NE, NJ, TN, NY, IN, CO, GA, OK,…Official notice →