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Illumina, Inc. recalls Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Recalled April 6, 2022 · FDA recall Z-0854-2022 · Illumina
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. · FDA Class II
Units
674 instruments
Sold at
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
Description
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.
Product
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Manufacturer(s)
Illumina, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →