Recall Z-1977-2023 ยท PFF High Throughput Dna Sequence Analyzer
Illumina, Inc.
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
| Date | Jun 16, 2023 (initiated Apr 5, 2023) |
| Status | Completed |
| Reason | Cybersecurity vulnerability concerning the software used for sequencing instruments. |
| Root cause | Software Manufacturing/Software Deployment |
| 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 |
| 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, Malt |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.