MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
This recall has been completed (originally issued June 16, 2023).
- Company
- Illumina, Inc.
- Recall Initiated
- April 5, 2023
- Posted
- June 16, 2023
- Recall Number
- Z-1977-2023
- Quantity
- 740 units
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Cybersecurity vulnerability concerning the software used for sequencing instruments.
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, Germany, Guatemala, Hong Kong, Hungary, IT Italy, Japan, Latvia, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russian Fed., Saudi Arabia, SG Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Utd. Arab Emir., Vietnam, Argentina, Aerbaijan, Belgium, Bosnia-Herz., Finland, Greece, Iceland, Ireland, Israel, Japan, Nigeria, NL Norway, Romania, Serbia, Slovakia, South Africa, T¿rkiye, Ukraine.
Lot / Code Info
UCS Versions: UCS 2.5.0/ UDI-DI: (00)816270020002
Root Cause
Software Manufacturing/Software Deployment
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.