Recall Z-0322-2027 ยท PFF High Throughput Dna Sequence Analyzer
Illumina, Inc.
NovaSeq 6000Dx Instrument REF: 20068232, FOR IN VITRO DIAGNOSTIC USE
| Date | Oct 30, 2026 (initiated May 8, 2024) |
| Status | Open, Classified |
| Reason | (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, servers, or computers) and in vitro diagnostic devices which may result in compromised data transmission. |
| Root cause | Labeling design |
| Action | On May 8, 2024, Illumina, Inc. issued a Urgent Medical Device Recall via email. Illumina ask consignees to take the following 1. Download & read this Cybersecurity Guidance document. The full hyperlink is below. https://support.illumina.com/support-content/cyberguidance.html 2. For Each Product Connected to the Customer Network: work with your internal IT department to determine which secure protocol works best in your environment and to implement the appropriate configuration change. Note: a change to the network protocol affects both Dx and RUO modes simultaneously therefore there is no n |
| Quantity | 41 units |
| Distribution | Worldwide - US Nationwide distribution including in the states and territory of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of AE, AR, AT, AU, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.