In the agency's Nov 11, 2026 enforcement report · Ongoing
Nextseq 550Dx Instrument REF: 20005715, FOR IN VITRO DIAGNOSTIC USE
Illumina, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Illumina, Inc. · 5200 Illumina Way · San Diego, CA · 92122-4616
Is this the product you have?
- Nextseq 550Dx Instrument REF20005715, FOR IN VITRO DIAGNOSTIC USE
- Lot codes and dates
- All Lots/UDI00816270020125
- Amount recalled
- 1233 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
(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.
This product could cause temporary or reversible health problems — stop using it.
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