RegWardenFDA facility compliance records
Company

Illumina, Inc.

7 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2014: 3 recalls; 2022: 2 recalls; 2023: 1 recalls; 2025: 1 recalls3’14’15’16’17’18’19’20’212’221’23’241’25’26
  • Recalls (7)

Registered facilities (3)

Recalls & enforcement

  • Class IIOngoing2025-10-28
    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…
  • Class IICompleted2023-04-05
    Cybersecurity vulnerability concerning the software used for sequencing instruments.
  • Class IICompleted2022-05-03
    cybersecurity vulnerability
  • Class IICompleted2022-02-22
    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 circuit results in the device being inoperable.
  • Class IITerminated2014-11-13
    It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report insertions or deletions at specific genomic locations with respect to the primer.
  • Class IIITerminated2014-11-06
    Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument.
  • Class IITerminated2014-07-28
    A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Illumina, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10030352-illumina-inc/

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