FDA Enforcement
Class III
Terminated
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Recall: Z-0850-2015
·
Reported December 31, 2014
Enforcement
- Recall Number
- Z-0850-2015
- Event ID
- 69715
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Illumina Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 31, 2014
- Initiation Date
- November 6, 2014
- Classification Date
- December 23, 2014
- Termination Date
- March 17, 2015
- Address
- 5200 Illumina Way, San Diego, CA, 92121, United States
Description
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
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 Info
Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.
Distribution
US: MD, NY Non-US: France
Quantity
19 units