Devices

Device Recall Verigene Warfarin Metabolism Nucleic Acid Test Cartridge

Model / Serial
Lot Numbers 121907002B, 010708002A, 012108002A, 012108002C, 012208002C, 012408002B, 012808002A, and 020608002A
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide; USA including states of Kentucky, Michigan, Tennessee, Texas, Louisiana, Connecticut, Illinois, and California.
Product Description
Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug metabolizing enzyme genotyping system; Nanosphere, Inc., 4088 Commercial Ave., Northbrook, IL 60062
Manufacturer
Nanosphere, Inc.
1 Event
- Recall of Device Recall Verigene Warfarin Metabolism Nucleic Acid Test Cartridge

Manufacturer

Nanosphere, Inc.

Manufacturer Address
Nanosphere, Inc., 4088 Commercial Ave, Northbrook IL 60062-1829
Manufacturer Parent Company (2017)
Luminex Corporation
Source
USFDA

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