Recall archive / FDA device enforcement
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD — FDA record Z-0854-2022
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 22, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
- 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.
- Classification
- Class II
- Recalling firm
- Illumina, Inc.
- Quantity
- 674 instruments
- Agency-reported status
- Completed
- Source record identifier
- Z-0854-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 6, 2022
- Recall initiation date
- Feb 22, 2022
- Center classification date
- Mar 31, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.