Illumina NextSeq 550Dx — Class II medical device recall Z-0854-2022
Completed recall by Illumina, Inc., reported 2022-04-06, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnec
| Recall number | Z-0854-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Illumina, Inc., San Diego, CA, United States |
| Recall initiated | 2022-02-22 |
| Classified | 2022-03-31 |
| Reported by FDA | 2022-04-06 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MD, MI, MN, NC, NE, NJ, NM, NY, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV |
| Countries outside the US | AE, AT, AU, BE, CH, CL, CN, DE, DK, ES, FI, FR, GB, HU, IE, IT, JP, KR, LV, NL, NO, PL, PT, RO, SA, SE, SG, SK, TR, VN, ZA |
| Quantity | 674 instruments |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00816270020125 |
| Lot numbers | NDX550110, NDX550843 |
| Model numbers | 20005715 |
Product
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0854-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.