RecallReported October 7, 2026
Class II recall by Illumina, Inc.
NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
FDA's enforcement report of October 7, 2026 lists a Class II recall by Illumina, Inc. of San Diego, CA. Product: NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130. Status: Ongoing.
On the record
- Recalling firm
- Illumina, Inc.
- Location
- San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-0068-2027
- Product type
- Devices
- Recall initiated
- 2024-09-17
- Reported by FDA
- 2026-10-07
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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