Device product
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Z-0850-2015
Product summary
- Firm
- Illumina Inc
- Event
- Event 69715
- Status
- Terminated
- Classification
- Class III
- Quantity
- 19 units
- Official record key
device-enforcement:Z-0850-2015
Official wording
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.
Code information: Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.
Distribution pattern: US: MD, NY Non-US: France
Derived failure modes
-
Unknown
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.