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Moderate riskFDA DeviceClass II

Illumina MiSeq Dx instrument recalled for cybersecurity flaw

Illumina is recalling about 1,193 MiSeq Dx diagnostic instruments because a cybersecurity weakness was found in how the device communicates with a lab's network storage, servers, or computers. This could compromise data sent between them. The recall notice reports no injuries.

From the FDA notice · Read the official notice ↗

What to do

  1. Check whether your MiSeq Dx instrument is covered by UDI 00816270020002, which applies to all lots.
  2. Contact Illumina for guidance on the recall and any steps to secure the instrument's connections.
  3. Ask your lab's IT or compliance staff to review how the instrument connects to your network.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
MiSeq Dx Instrument REF: DX-410-1001 / 15036706, FOR IN VITRO DIAGNOSTIC USE
Sold in
Nationwide
Made for
All ages

This recall covers 5 products — see all of them.

Details

Units affected
1193 units
Illnesses reported
None reported
Manufactured in
5200 Illumina Way, San Diego, California, United States
Classification
Class II
Recall number
Z-0321-2027

In the FDA's words

Description
MiSeq Dx Instrument REF: DX-410-1001 / 15036706, 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: 00816270020002 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: 1193 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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