Recall Z-1976-2023— Illumina, Inc.

Name: FDA recall Z-1976-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-05

Class II · Completed

Class II FDA medical device recall by Illumina, Inc., initiated 2023-04-05. FDA's recall record names no specific 510(k) clearance for this event. Product: NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software. Reason: Cybersecurity vulnerability concerning the software used for sequencing instruments..

Recalling firm: Illumina, Inc.
Classification: Class II
Status: Completed
Initiated: 2023-04-05
Firm location: San Diego, CA, United States

Product description

NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software

Reason for recall

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Data sourced from openFDA. This site is unofficial and independent of the FDA.