Medical device recalls Moderate risk

The Binding Site Group, Ltd. recalls Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma a…

Recall date
November 28, 2012
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1050-2017
FDA classification
Class II
Brand / firm
The Binding Site Group, Ltd.
Sold / distributed
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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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