Binding Site Optilite Beta-2-Microglobulin Urine Kit Recalled for Performance Defect
The Binding Site Group is recalling 20 Optilite Beta-2-Microglobulin Urine Kits because they do not meet the stated antigen excess protection claim.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect is a performance issue (antigen excess protection) rather than a direct physical hazard like fire or shock, and no injuries are reported.
Plain-English summary
The Binding Site Group, Ltd. is recalling 20 units of the Optilite Beta-2-Microglobulin Urine Kit (Ref LK043.L.OPT.A). The affected product is Lot 407460, UDI 05051700017688. This in-vitro diagnostic (IVD) kit is intended for the quantitative measurement of beta-2-microglobulin in urine to aid in the diagnosis of active rheumatoid arthritis and kidney disease.
The recall was initiated because the product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use. This performance defect may affect the accuracy of test results.
The 20 kits were distributed to California. There was no foreign, military, or government distribution. Users should stop using the affected kits and contact The Binding Site Group, Ltd. for further instructions.
The recalled product
- 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-microglo
- Manufacturer
- The Binding Site Group, Ltd.
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 407460
- UDI 05051700017688
Distribution
Distributed in 1 state:
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