The Binding Site Group, Ltd. recalls OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565

Recall date

July 29, 2019

Source

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

Recall number

Z-1327-2020

FDA classification

Class II

Brand / firm

The Binding Site Group, Ltd.

Sold / distributed

CA, PA, FL, AR, SD, MA, WV, AL, GA, IL, MN, MD, AZ, NC, TN, WA, MI, NY, KY, SC, IN, OR, NE, OH, TX, VT, WA, UT, IA,

Why it was recalled

There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.

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 IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565