illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model:… — Class II medical device recall Z-1259-2022
Completed recall by Illumina, Inc., reported 2022-06-22, distributed nationwide. cybersecurity vulnerability
| Recall number | Z-1259-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Illumina, Inc., San Diego, CA, United States |
| Recall initiated | 2022-05-03 |
| Classified | 2022-06-13 |
| Reported by FDA | 2022-06-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, CA, CH, CL, CN, CY, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, GT, HU, IE, IT, JP, KR, LT, LU, LV, MA, MT, NG, NL, NO, NZ, PE, PH, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TR, UA, VN, ZA |
| Quantity | 1,014 instruments |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00816270020002, 00816270020699 |
| Model numbers | 15036706, 20014053, DX-410-1001 |
Product
illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
Reason for recall
cybersecurity vulnerability
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-1259-2022. 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.