Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Binding Site Optilite Beta-2-Microglobulin Urine Kit Recalled by The Binding Site Group, Ltd. Due to The product is not meeting the antigen excess...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact The Binding Site Group, Ltd. directly.
Affected Products
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.
Quantity: 20 kits distributed to the U.S.
Why Was This Recalled?
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
Where Was This Sold?
This product was distributed to 1 state: CA
About The Binding Site Group, Ltd.
The Binding Site Group, Ltd. has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report