Device recall

Z-1977-2023: MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS)…

FDA device recall · Class II · Illumina, Inc.

Key facts

Recall number (Z-number) Z-1977-2023
Recall event 92233
Product MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Product code PFF
Recalling firm Illumina, Inc.
Recall class Class II
Status Completed
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)