FDA recall Z-1260-2022

Product

illumina Model NextSeq 550 Dx REF 20005715

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, Egypt, Finland, France, Georgia, Germany, Guatemala, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam.

Key facts

Status

Completed

Initiation date

2022-05-03

Report date

2022-06-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1260-2022