Recall Z-1977-2023— Illumina, Inc.

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

MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) 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.