Device product
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Z-0854-2022
Product summary
- Firm
- Illumina, Inc.
- Event
- Event 89699
- Status
- Completed
- Classification
- Class II
- Quantity
- 674 instruments
- Official record key
device-enforcement:Z-0854-2022
Official wording
Reason: 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.
Code information: Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125
Distribution pattern: 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
Derived failure modes
-
Unknown
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.