Illumina MiSeqDx Universal Kit 1 — Class II medical device recall Z-0849-2015
Terminated recall by Illumina Inc, reported 2014-12-31, distributed in AZ, CA, GA, OH, VA. It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx U
| Recall number | Z-0849-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Illumina Inc, San Diego, CA, United States |
| Recall initiated | 2014-11-13 |
| Classified | 2014-12-23 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2015-03-18 |
| Distributed | AZ, CA, GA, OH, VA |
| Countries outside the US | FR |
| Quantity | 13 units |
| Reason classes | software |
| Serial numbers | M70103, M70108, M70130, M70165, M70166, M70172, M70175, M70189 |
Product
Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument.
Reason for recall
It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report insertions or deletions at specific genomic locations with respect to the primer.
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-0849-2015. 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.