Recall Weekly
Moderate riskFDA DeviceClass II

Illumina VeriSeq Onsite Server V2 recalled for cybersecurity flaw

Illumina recalled 201 VeriSeq Onsite Server V2 units because a cybersecurity weakness was found in how the server communicates with in vitro diagnostic devices and customer-provided computers, storage, or network equipment. This weakness may compromise data transmission. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Contact Illumina or your laboratory's supplier to confirm whether your server is included in this recall.
  2. Ask Illumina what remedy or software update is available before making changes to the system.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
VeriSeq Onsite Server V2 REF: 20047000
Sold in
Nationwide
Made for
All ages

This recall covers 5 products — see all of them.

Details

Units affected
201 units
Illnesses reported
None reported
Manufactured in
5200 Illumina Way, San Diego, California, United States
Classification
Class II
Recall number
Z-0324-2027

In the FDA's words

Description
VeriSeq Onsite Server V2 REF: 20047000 (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: N/A 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: 201 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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