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

FDA device recall Z-1977-2023 · posted 2023-06-16 · Completed

Recall details

Recalling firm

Illumina, Inc.

Reason for recall

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Action taken

On April 5, 2023, Illumina issued a "Urgent Medical Device Recall" Notification via XXX. Illumina ask consignees to take the following actions: 1. Download & Install Software Patch: For Each Instrument Connected to the Internet: 2. Change UCS User Configuration(s): Change the UCS User configuration to standard user (with no administrator permissions) by following the instructions available in the customer communication. 3. Complete and return the Verification Form after carrying out all the steps in the instructions provided on your specific instrument(s) identified as affected in Table 1. 4. If you experience an adverse event due to this vulnerability with the use of any of the affected products, please report it to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. You can complete and submit the report online at www.fda.gov/medwatch/report.htm.

Root cause

Software Manufacturing/Software Deployment

Status

Completed

Product code

PFF

Quantity affected

740 units

Distribution

Worldwide distribution - US Nationwide and the countries of Algeria, AU Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Egypt, FR France, GB Georgia, Germ

Date initiated

2023-04-05

Date posted

2023-06-16

Location

San Diego, CA