Illumina NovaSeq 6000Dx Recalled for Server Security Vulnerability
Illumina is recalling 80 NovaSeq 6000Dx and DRAGEN Server units worldwide due to a security vulnerability in the server component.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a security vulnerability, which is a theoretical risk without reported physical injury or illness, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Illumina, Inc. is recalling 80 units of the NovaSeq 6000Dx including DRAGEN Server (Catalog Number 20068232) and the Illumina DRAGEN Server for NextSeq 550Dx (Catalog Number 20086130). These instruments are intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays.
The recall is due to a security vulnerability in the server component of the instruments. This is a retrospectively reported correction.
The affected units were distributed worldwide, including in the United States (TX, KS, NC, CA, UT, KA, MA, NJ, MD) and in Spain, South Korea, Japan, Australia, Italy, United Arab Emirates, Sweden, United Kingdom, Czech Republic, Singapore, Austria, Poland, France, Germany, Finland, Switzerland, and Slovakia. Specific serial numbers are listed in the agency's recall record.
The recalled product
- Product
- NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
- Manufacturer
- Illumina, Inc.
- Hazard
- Affected units
- 80
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog/UDI-DI/Serial Numbers: 20068232/00816270020637/ADX00020
- ADX00114
- ADX00121
- ADX00124
- ADX00147
- ADX00151
- ADX00139
- ADX00105
- ADX00103
- ADX00108
- ADX00104
- ADX00106
- ADX00101
- ADX00115
- ADX00111
- ADX00112
- ADX00117
- ADX00119
- ADX00116
- ADX00118
Distribution
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