Cl III Illumina MiSeqDx

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

___________________________________

Upcoming Training

QSS Software Validation
Planned Instructors:  Brian Pate, John Murray
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)! 

Multi-Student Discounts as well!

Email training@softwarecpr.com
to receive discount

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.