Recall Weekly
Moderate riskFDA DeviceClass II

Illumina NovaSeq 6000Dx sequencer recalled over cybersecurity flaw

Illumina recalled 41 NovaSeq 6000Dx instruments, a diagnostic lab sequencer, because a cybersecurity vulnerability was found in how the device communicates with customer-provided network storage, servers, or computers. The flaw may compromise data transmission. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check whether your instrument matches UDI 00816270020637 (REF 20068232).
  2. Contact Illumina for guidance on the cybersecurity issue and next steps.
  3. Review your lab's network and data-transfer setup with your IT or security team until you receive guidance.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
NovaSeq 6000Dx Instrument REF: 20068232, FOR IN VITRO DIAGNOSTIC USE
Sold in
Nationwide
Made for
All ages (under 120 years)

This recall covers 5 products — see all of them.

Details

Units affected
41 units
Illnesses reported
None reported
Manufactured in
5200 Illumina Way, San Diego, California, United States
Classification
Class II
Recall number
Z-0322-2027

In the FDA's words

Description
NovaSeq 6000Dx Instrument REF: 20068232, 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:00816270020637 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: 41 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.

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