Drug recall
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina…
FDA recall event 69715 · Class III · Illumina Inc
Key facts
| Event ID | 69715 |
|---|---|
| Recall numbers | Z-0850-2015 |
| Recalling firm | Illumina Inc |
| Product type | Devices |
| Products | Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Nov 6, 2014 |
| Report date | Dec 31, 2014 |
| Termination date | Mar 17, 2015 |
| 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: