Recall Weekly
Moderate riskFDA DeviceClass II

Illumina NextSeq 550Dx instrument recalled over cybersecurity flaw

Illumina is recalling about 1,233 NextSeq 550Dx instruments used for in vitro diagnostic testing. A cybersecurity weakness in how the device communicates with customer-provided network storage, servers, or computers could allow data transmission to be compromised. No injuries have been reported.

From the FDA notice · Read the official notice ↗

Update since first reported

  • Oct 30, 2026FDA added products to this recall

What to do

  1. Contact Illumina or your laboratory's device administrator for guidance on this instrument.
  2. Ask your IT or security team to review the network connections used by the NextSeq 550Dx.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Nextseq 550Dx Instrument REF: 20005715, FOR IN VITRO DIAGNOSTIC USE
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 5 products — see all of them.

Details

Units affected
1233 units
Illnesses reported
None reported
Manufactured in
5200 Illumina Way, San Diego, California, United States
Classification
Class II
Recall number
Z-0320-2027

In the FDA's words

Description
Nextseq 550Dx Instrument REF: 20005715, FOR IN VITRO DIAGNOSTIC USE (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, servers, or computers) and in vitro diagnostic devices which may result in compromised data transmission. All Lots/UDI: 00816270020125 Distribution: Worldwide - US Nationwide distribution including in the states and territory of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of AE, AR, AT, AU, BE, BG, CA, CH, CL, CN, CY, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, Ghana, GR, GT, HK, HU, IE, IL, IS, IT, JP, KR, KW, LT, LU, LV, MA, MT, NG, NL, NO, NZ, PE, PH, PL, PT, QA, RO, RU, SA, SE, SG, SI, TH, TR, UA, VN, ZA. Affected quantity: 1233 units
Hazard
(Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, servers, or computers) and in vitro diagnostic devices which may result in compromised data transmission.

5 products in this recall

Illumina sequencing instruments recalled for cybersecurity vulnerability

Illumina is recalling five diagnostic sequencing instruments and servers: NextSeq 550Dx, MiSeq Dx, NovaSeq 6000Dx, DRAGEN Server for NextSeq 550Dx, and VeriSeq Onsite Server V2. The recall covers about 2,700 units, all sold for in vitro diagnostic (laboratory testing) use. A cybersecurity weakness in how these devices communicate with customer-provided computers, storage, or servers could allow data transmission to be compromised. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Also reported as

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