FDAFDA · Food and drugs·Recall number Z-1977-2023
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Published June 28, 2023 · Recall initiated: April 5, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Cybersecurity vulnerability concerning the software used for sequencing instruments.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Illumina, Inc.
- Distributor
- 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
- UCS Versions: UCS 2.5.0/ UDI-DI: (00)816270020002
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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