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Completed

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

FDA Recall Z-1976-2023 · Posted 2023-06-16

Recalling FirmIllumina, Inc.
Recall StatusCompleted
Product CodePFF
Date Initiated2023-04-05
Product Quantity1067 units

Reason for Recall

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Firm Action

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

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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