Device recall
Nextseq 550Dx Instrument REF: 20005715, FOR IN VITRO DIAGNOSTIC USE
- Recall number
- Z-0320-2027
- Event id
- 99957
- Status
- Open, Classified
- FDA classification
- Class II
- Recalling firm
- Illumina, Inc.
- Posted
- Oct 30, 2026
- Initiated
- May 8, 2024
- Product code
- PFF
- Device type
- High Throughput Dna Sequence Analyzer
- 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
- Quantity
- 1233 units
- Code info
- All Lots/UDI: 00816270020125
- 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.
- Location
- San Diego, CA