MiSeq Dx Instrument recall: Software Issue
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Why was MiSeq Dx Instrument recalled?
Cybersecurity vulnerability concerning the software used for sequencing instruments.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UCS Versions: UCS 2.5.0/ UDI-DI: (00)816270020002
- Product
- MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
- Recalling firm
- Illumina, Inc.
- Quantity
- 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, 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.
- Recall date
- June 28, 2023
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)