The Binding Site Group, Ltd. recalls Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.

Recall date

July 5, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1043-2017

FDA classification

Class II

Brand / firm

The Binding Site Group, Ltd.

Sold / distributed

U.S. distribution to the following; AR, PA, GA, NC, KY, VA, CA. Foreign distribution to the following; Uk, Germany, France, Italy, Spain, Czech Republic, Portugal, Belgium.

Why it was recalled

Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards.

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

What was recalled

Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.