Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro… — Class III medical device recall Z-0850-2015
Terminated recall by Illumina Inc, reported 2014-12-31, distributed in MD, NY. Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSe
| Recall number | Z-0850-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Illumina Inc, San Diego, CA, United States |
| Recall initiated | 2014-11-06 |
| Classified | 2014-12-23 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2015-03-17 |
| Distributed | MD, NY |
| Countries outside the US | FR |
| Quantity | 19 units |
| Reason classes | potency, software |
| Serial numbers | M00533L, M70106, M70114 |
Product
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Reason for recall
Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument.
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-0850-2015. 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.