Devices

Device Recall Human Lambda Free SPAPlus Kit

Model / Serial
Lot #323278, 327963
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain.
Product Description
Human Lambda Free SPAPlus Kit || Product Code: LK018.S || Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
Manufacturer
The Binding Site Group, Ltd.
1 Event
- Recall of Device Recall Human Lambda Free SPAPlus Kit

Manufacturer

The Binding Site Group, Ltd.

Manufacturer Address
The Binding Site Group, Ltd., 8 Calthorpe Road, Birmingham United Kingdom
Manufacturer Parent Company (2017)
Cidron Iugo Sarl
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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