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Illumina Inc recalls Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx P
Recalled December 31, 2014 · FDA recall Z-0850-2015 · Illumina
Hazard
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. · FDA Class III
Units
19 units
Sold at
US: MD, NY Non-US: France
Description
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.
Product
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Manufacturer(s)
Illumina Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →