Illumina, Inc. Recall 92233
Description: MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Illumina, Inc. Recall 92233 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1977-2023 |
| Event ID | 92233 |
| Event Description | MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software. |
| Product Type | Devices |
| 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. |
| Quantity | 740 units |
| Recall Reason | Cybersecurity vulnerability concerning the software used for sequencing instruments. |
| Device Classification | 20230628 |
| Device Code Info | UCS Versions: UCS 2.5.0/ UDI-DI: (00)816270020002 |
| Center Classification Date | 20230616 |
| Recall Initiation Date | 20230405 |
| Recalling Firm | Illumina, Inc. |
| Initial Notification | Letter |
| Similar To |