Illumina, Inc.: illumina Model NextSeq 550 Dx REF 20005715

Is my product affected?

illumina Model NextSeq 550 Dx REF 20005715

• UPC 00816270020125

Check against the official notice below — it lists the full affected range.

What happened

Illumina, Inc. is recalling 799 NextSeq 550 Dx instruments (Model Number 20005715) worldwide due to a cybersecurity vulnerability. The affected instruments contain Local Run Manager Software versions 1.3.1 through 3.0 and were distributed across the United States and internationally to countries including Canada, Australia, China, and many others.

The recall notice does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

cybersecurity vulnerability

Details from the source

Reason for recall: cybersecurity vulnerability 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, Austria, Belgium, Bulgaria, Bosnia/Herzegovina, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Egy Quantity: 799 instruments Lot/code info: Model Numbers: 20005715 UDI-DI Code: 00816270020125 All Instruments containing Local Run Manager (LRM) Software version: v.1.3.1 to 3.0 Installed Product ID: U.S.: NDX550779-15073937 NDX550504-15073937 NDX550732-15073937 NDX550287-15073937 NDX550802-15073937 NDX550691-15073937 NDX550656-15073937 NDX550725-15073937 NDX550736-15073937 NDX550754-15073937 NDX550151-15073937 NDX550996-15073937 NDX550916-15073937 NDX550420-15073937 NDX550715-15073937 NDX550726-15073937 NDX550729-15073937 NDX550730-15073937 NDX550712-15073937 NDX550722-15073937 NDX550660-15073937 NDX550603-15073937 NDX550601-15073937 NDX550595-15073937 NDX550553-15073937 NDX550568-15073937 NDX550579-15073937 NDX550586-15073937 NDX550590-15073937 NDX550561-15073937 NDX550522-15073937 NDX550535-15073937 NDX550563-15073937 NDX550485-15073937 NDX550547-15073937 NDX550552-15073937 NDX550560-15073937 NDX550537-15073937 NDX550531-15073937 NDX550532-15073937 NDX550533-15073937 NDX550501-15073937 NDX550503-15073937 NDX550474-15073937 NDX550445-15073937 NDX550432-15073937 NDX550378-15073937 NDX550369-15073937 NDX550374-15073937 NDX550115-15073937 NDX550370-15073937 NDX550376-15073937 NDX550381-15073937 NDX550361-15073937 NDX550257-15073937 NDX550313-15073937 NDX550288-15073937 15073937NDX550261 NDX550207-15073937 NDX550149-15073937 NDX550138-15073937 NDX550123-15073937 NDX550105-15073937 NDX550136-15073937 NDX550140-15073937 NDX550914-15073937 NDX550968-15073937 NDX550851-15073937 NDX550962-15073937 NDX550763-15073937 NDX5505

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.22022-05-03
• NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.22022-05-03
• STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT2022-05-03
• Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm2022-05-03
• illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx2022-05-03

All FDA (Device enforcement) recalls