MiSeq Dx Instrument REF: DX-410-1001 / 15036706, FOR IN VITRO DIAGNOSTIC USE

(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.

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 need to boot into each mode separately to take the necessary action. 3. Complete and return the Verification Form after carrying out all the steps in the instructions provided on your specific product(s) identified as affected in Table 1.

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, BE, BG, CA, CH, CL, CN, CY, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, Ghana, GR, GT, HK, HU, IE, IL, IS, IT, JP, KR, KW, LT, LU, LV, MA, MT, NG, NL, NO, NZ, PE, PH, PL, PT, QA, RO, RU, SA, SE, SG, SI, TH, TR, UA, VN, ZA.