FDA recall, , Moderate risk
Illumina NextSeq 550Dx, MiSeq Dx, NovaSeq 6000Dx Instruments
Illumina NextSeq 550Dx, MiSeq Dx, NovaSeq 6000Dx Instruments have a cybersecurity vulnerability that may compromise data transmission.
Illumina began this recall on May 8, 2024, and reported it to FDA retroactively. FDA posted it on Oct 30, 2026; it is still open. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
Illumina, Inc. of San Diego, California, voluntarily recalled five in vitro diagnostic devices because of a retrospectively reported cybersecurity vulnerability in the communication protocol between customer-provided infrastructure, such as network storage, servers, or computers, and the devices. The vulnerability may result in compromised data transmission.
The affected products include the VeriSeq Onsite Server V2, NextSeq 550Dx Instrument, Illumina DRAGEN Server for NextSeq 550Dx, MiSeq Dx Instrument, and NovaSeq 6000Dx Instrument.
The recall began May 8, 2024, and customers were notified by e-mail. The devices were distributed nationwide across the United States and internationally.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
5 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Illumina Dragen Server for NextSeq 550Dx REF: 20086130,
- Lot code
- All Lots/UDI: N/A
VeriSeq Onsite Server V2 REF: 20047000
- Lot code
- All Lots/UDI: N/A
Nextseq 550Dx Instrument REF: 20005715, for in Vitro Diagnostic Use
- Lot code
- All Lots/UDI: 00816270020125
MiSeq Dx Instrument REF: DX-410-1001 / 15036706, for in Vitro Diagnostic Use
- Lot code
- All Lots/UDI: 00816270020002
NovaSeq 6000Dx Instrument REF: 20068232, for in Vitro Diagnostic Use
- Lot code
- All Lots/UDI:00816270020637
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
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.
- Recalled by
- Illumina, Inc.San Diego, California
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 99957
- Recall numbers
- Z-0320-2027 to Z-0324-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
All recalls from Illumina, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Illumina began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
