FDA Device recall Z-0854-2022
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
- FDA Device
- Class II
- completed
- Published 2022-04-06
On 2022-04-06 the FDA classified a Class II recall of Illumina NextSeq 550Dx, REF: 20005715, CE, IVD by Illumina, citing 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 reconn….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0854-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-02-22 |
| Published | 2022-04-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Illumina |
| Distribution | 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 |
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.
Identifiers
| code_info | Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0854-2022%22
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