Device recall

Z-0068-2027: NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina…

FDA device recall · Class II · Illumina, Inc.

Key facts

Recall number (Z-number) Z-0068-2027
Recall event 99585
Product NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
Product code PFF
Recalling firm Illumina, Inc.
Recall class Class II
Status Open, Classified
FEI number 3003218906

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)