Illumina, Inc.: illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx

Is my product affected?

illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx

• UPC 00816270020002
• UPC 00816270020699

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

What happened

Illumina, Inc. is recalling 1,014 MiSeq Dx instruments due to a cybersecurity vulnerability. The affected devices include models DX-410-1001, 15036706, and 20014053 with software versions 1.3.1 to 3.0. These instruments were distributed worldwide and throughout numerous U.S. states, as well as to countries including Canada, China, Australia, and many others.

The record 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: 1,014 instruments Lot/code info: Model Numbers: DX-410-1001; 15036706; 20014053; UDI-DI Code: 00816270020002 00816270020699 All Instruments containing Software version: v.1.3.1 to 3.0 Installed Product ID: U.S.: M71006-20014737 M70955-20014737 M70992-20014737 M70999-20014737 M70957-20014737 M70989-20014737 M70983-20014737 M70979-20014737 M70971-20014737 M70977-20014737 M70968-20014737 M70938-20014737 M70951-20014737 M70770-20014737 M70956-20014737 M70958-20014737 M70946-20014737 M70939-20014737 M70922-20014737 M70905-20014737 M70932-20014737 M70904-20014737 M70925-20014737 M70894-20014737 M70906-20014737 M70892-20014737 M70899-20014737 M70897-20014737 M70865-20014737 M70882-20014737 M70879-20014737 M70883-20014737 M70868-20014737 M70880-20014737 M70878-20014737 M70864-20014737 M70858-20014737 M70861-20014737 M70797-20014737 M70842-20014737 M70843-20014737 M70855-20014737 M70848-20014737 M70840-20014737 M70826-20014737 M70818-20014737 M70822-20014737 M70827-20014737 M70815-20014737 M70296-15037414 M70813-20014737 M70814-20014737 M70810-20014737 M70799-20014737 M70809-20014737 M70803-20014737 M70804-20014737 M70805-20014737 M70806-20014737 M70808-20014737 M70807-20014737 M70767-20014737 M70795-20014737 M70789-20014737 M70790-20014737 M70792-20014737 M70793-20014737 M70784-20014737 M70791-20014737 M70794-20014737 M70742-20014737 M70723-20014737 M70781-20014737 M70776-20014737 M70778-20014737 M70779-20014737 M70773-20014737 M70739-20014737 M70774-20014737 M70744-20014737 M70771-20014737 M70777-20014737 M70750-20

Source

Official record: FDA (Device enforcement) ↗

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

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