Devices

Device Recall Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay

Model / Serial
Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
US: MD, NY Non-US: France
Product Description
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Manufacturer
Illumina Inc
1 Event
- Recall of Device Recall Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay

Manufacturer

Illumina Inc

Manufacturer Address
Illumina Inc, 5200 Illumina Way, San Diego CA 92121
Manufacturer Parent Company (2017)
Illumina Inc.
Source
USFDA

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