Z-0850-2015 Class III Terminated
FDA device recall Z-0850-2015 was initiated by Illumina Inc on November 6, 2014 and is designated Class III. 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. The recall status is terminated (terminated March 17, 2015). Affected quantity: 19 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 31, 2014
- Initiation Date
- November 6, 2014
- Termination Date
- March 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 units
Product Description
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
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.
Distribution Pattern
US: MD, NY Non-US: France
Code Information
Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.