Class 2 Device Recall MiSeq Dx Instrument

• Date Initiated by Firm: May 08, 2024
• Date Posted: October 30, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0321-2027
• Recall Event ID: 99957
• Product Classification: High throughput DNA sequence analyzer - Product Code PFF
• Product: MiSeq Dx Instrument REF: DX-410-1001 / 15036706, FOR IN VITRO DIAGNOSTIC USE
• Code Information: All Lots/UDI: 00816270020002
• FEI Number: 3003218906
• Recalling Firm/ Manufacturer: Illumina, Inc.; 5200 Illumina Way; San Diego CA 92122-4616
• For Additional Information Contact: Christine Douglass; 858-202-4500
• Manufacturer Reason for Recall: (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.
• FDA Determined 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 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.
• Quantity in Commerce: 1193 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, 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.