The Binding Site Group, Ltd. recalls Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding…

Recall date

March 9, 2018

Source

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

Recall number

Z-1301-2018

FDA classification

Class II

Brand / firm

The Binding Site Group, Ltd.

Sold / distributed

US Distribution was made to CA. There was no foreign/military/government distribution.

Why it was recalled

The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.

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

What was recalled

Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings.