Illumina Worklist Manager — Class II medical device recall Z-2611-2014
Terminated recall by Illumina Inc, reported 2014-09-17, distributed nationwide. A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to p
| Recall number | Z-2611-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Illumina Inc, San Diego, CA, United States |
| Recall initiated | 2014-07-28 |
| Classified | 2014-09-08 |
| Reported by FDA | 2014-09-17 |
| Terminated | 2014-11-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, DE, FR, GB, IT, NO |
| Quantity | 35 |
| Reason classes | software |
Product
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.
Reason for recall
A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended
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-2611-2014. 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.