FDA-Device2017-01-25Class II
Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
The Binding Site Group, Ltd.
Hazard
A change in the calibration curve causing an increase in false prozone flags.
Sold states
Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.
Affected count
3,088
Manufactured in
8 Calthorpe Road, Birmingham, United Kingdom
Products
Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1053-2017Don't want to check this manually?
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