FDA-Device2017-01-25Class II

Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

The Binding Site Group, Ltd.
Hazard

Calibration curve activity has increased over time in the kit lots listed.

Sold states
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.
Affected count
1,002
Manufactured in
8 Calthorpe Road, Birmingham, United Kingdom
Products
Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1050-2017

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