FDA-Device2022-04-06Class II
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Illumina, Inc.
Hazard
There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable.
Sold states
US: PA, WA, CA, MI, FL, MD, AR, UT NC, Fl, IL, NE, NJ, TN, NY, IN, CO, GA, OK, TX, CT, SD, NM, VA, AL, LA, SC, WV, OR, IA, AZ, MN OUS: Australia Austria Belgium Chile China Denmark Finland France Germany Hungary Ireland Italy Japan Latvia Netherlands Norway Poland Portugal Romania Russian Federation Saudi Arabia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom Vietnam
Affected count
674 instruments
Manufactured in
5200 Illumina Way, N/A, San Diego, CA, United States
Products
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0854-2022Don't want to check this manually?
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