The Binding Site Group, Ltd. recalls Optilite IgG4 Kit Product Code: LK009.OPT.A

Recall date

December 23, 2016

Source

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

Recall number

Z-1089-2017

FDA classification

Class III

Brand / firm

The Binding Site Group, Ltd.

Sold / distributed

U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.

Why it was recalled

A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Optilite IgG4 Kit Product Code: LK009.OPT.A