Devices

Device Recall SYNCHRON System(s) Rheumatoid Factor (RF) Reagent

Model / Serial
Lot #M907325
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA including states of: AZ, CA, CO, IA, PA, NH, NV, NY, and WA; and countries of: Belgium, China, Czech Republic, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lebanon, Lithuania, Mexico, Netherlands, Russian Federation, South Africa, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.
Product Description
SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 || RF reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems CAL 5 Plus, is intended for quantitative determination of Rheumatoid Factor concentration in human serum or plasma.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Device Recall SYNCHRON System(s) Rheumatoid Factor (RF) Reagent

Manufacturer

Beckman Coulter Inc.

Manufacturer Address
Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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