Company: Illumina Inc.
Date of Enforcement Report 12/31/2014
Class lII:

PRODUCT

Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform. Recall Number Z-0850-2015

REASON
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..

RECALLING FIRM/MANUFACTURER
Illumina Inc, San diego, CA, on 11/6/2014. Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
19 units

DISTRIBUTION
US: MD, NY Non-US: France

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