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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
Recalled April 11, 2018 · FDA recall Z-1301-2018 · The Binding Site Group
Hazard
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use. · FDA Class II
Units
20 kits distributed to the U.S.
Sold at
US Distribution was made to CA. There was no foreign/military/government distribution.
Description
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
Product
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.
Manufacturer(s)
The Binding Site Group, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →