Drug recall
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage…
FDA recall event 68959 · Class II · Illumina Inc
Key facts
| Event ID | 68959 |
|---|---|
| Recall numbers | Z-2611-2014 |
| Recalling firm | Illumina Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended |
| Initiation date | Jul 28, 2014 |
| Report date | Sep 17, 2014 |
| Termination date | Nov 12, 2014 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 3003218906 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: