MiSeq Dx Instrument — Class II medical device recall Z-1977-2023
Completed recall by Illumina, Inc., reported 2023-06-28, distributed nationwide. Cybersecurity vulnerability concerning the software used for sequencing instruments.
| Recall number | Z-1977-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Illumina, Inc., San Diego, CA, United States |
| Recall initiated | 2023-04-05 |
| Classified | 2023-06-16 |
| Reported by FDA | 2023-06-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, CA, CH, CL, CN, CY, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, GR, GT, HK, HU, IE, IL, IS, IT, JP, KR, LT, LU, LV, MA, MT, NG, NL, NO, NZ, PH, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, UA, VN, ZA |
| Quantity | 740 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00816270020002 |
| Model numbers | M70101 |
Product
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Reason for recall
Cybersecurity vulnerability concerning the software used for sequencing instruments.
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-1977-2023. 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.