Recall Z-1259-2022 ยท PFF High Throughput Dna Sequence Analyzer
Illumina, Inc.
illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
| Date | May 3, 2022 |
| Status | Completed |
| Reason | cybersecurity vulnerability |
| Root cause | Software in the Use Environment |
| Action | On 05/03/2022, Illumina sent via email an "Urgent Medical Device Recall" Letter to customer informing them the cybersecurity vulnerability impacting the NextSeq 550 Dx and MiSeq Dx instruments with software versions 1.3 to 3.1 of the Local Run Manager (LRM) software installed. Customers are also being informed that Illumina has developed a software patch to protect against the exploitation of the vulnerability. Installation of the software patch will block remote access to the LRM web User Interface (web UI). For NextSeq 550Dx and MiSeq Dx instruments connected to the internet, the software p |
| Quantity | 1,014 instruments |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, and WV. The countries of Algeria, Australia, Austri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.