Recall Weekly
Moderate riskFDA DeviceClass II

Illumina DRAGEN Server recalled for cybersecurity vulnerability

Illumina is recalling the DRAGEN Server used with the NextSeq 550Dx diagnostic system. A cybersecurity weakness was found in how the server communicates with customer-provided networks, storage, and computers, which could compromise data transmission. No injuries have been reported, and 32 units are affected.

From the FDA notice · Read the official notice ↗

What to do

  1. Contact Illumina for guidance on the recall and any required steps for your device.
  2. Check whether your lab or facility has the affected DRAGEN Server for NextSeq 550Dx.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Illumina DRAGEN Server for NextSeq 550Dx REF: 20086130,
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 5 products — see all of them.

Details

Units affected
32 units
Illnesses reported
None reported
Manufactured in
5200 Illumina Way, San Diego, California, United States
Classification
Class II
Recall number
Z-0323-2027

In the FDA's words

Description
Illumina DRAGEN Server for NextSeq 550Dx REF: 20086130, (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: 32 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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