The Recall Desk

FDA (Devices) recall action 90160

Illumina, Inc. recalled 2 products on 2022-06-22

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2022-06-22
Critical
0
Units
1,813

Why these products were recalled

cybersecurity vulnerability

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2022-06-22

    Illumina NextSeq 550 Genetic Sequencer Cybersecurity Vulnerability Recall

    Illumina is recalling 799 NextSeq 550 Dx genetic sequencers due to a cybersecurity vulnerability in the Local Run Manager software. Affected devices have been distributed worldwide and in the United States.

    Product
    illumina Model NextSeq 550 Dx REF 20005715
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2022-06-22

    Illumina MiSeq Dx Sequencing Instruments Recalled Due to Cybersecurity Vulnerability

    Illumina is recalling approximately 1,014 MiSeq Dx sequencing instruments due to a cybersecurity vulnerability. The devices are distributed worldwide and throughout the United States.

    Product
    illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
    Category
    Distribution
    43 states