The Binding Site Group recalls their Optilite Beta-2-Microglobulin Urine Kit (Ref LK043.L.OPT.A) due to inaccurate test results. This IVD kit may not meet the claimed antigen excess protection level of 760mg/L, potentially leading to incorrect diagnosis of rheumatoid arthritis or kidney disease.
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
The Binding Site Group is recalling their Optilite Beta-2-Microglobulin Urine Kit (Ref LK043.L.OPT.A) because it may not provide accurate test results as claimed. This could lead to incorrect diagnosis of rheumatoid arthritis or kidney disease if used without proper validation.
The kit may not meet the claimed antigen excess protection level of 760mg/L, which is critical for accurate measurement of beta-2-microglobulin in urine. This inaccuracy could lead to incorrect diagnosis of kidney disease or rheumatoid arthritis if the test results are not validated by a healthcare provider.
People who use this urine test kit for diagnosing rheumatoid arthritis or kidney disease. Those with medical conditions requiring precise kidney function testing are most at risk.
Check for the product name 'Optilite Beta-2-Microglobulin Urine Kit' with reference number LK043.L.OPT.A. The kit was sold with lot number 407460 and unique device identifier 05051700017688.
Verify the product name, reference number, lot number, and unique device identifier on the kit label.
The kit may not meet the claimed antigen excess protection level of 760mg/L, which could lead to inaccurate test results for beta-2-microglobulin in urine.
Inaccurate test results could lead to incorrect diagnosis of rheumatoid arthritis or kidney disease if not validated by a healthcare provider.
Look for the product name 'Optilite Beta-2-Microglobulin Urine Kit' with reference number LK043.L.OPT.A, lot number 407460, and unique device identifier 05051700017688.
We’ve drafted a message you can send The Binding to request your refund or repair — edit it as you like.
Subject: Recall Z-1301-2018 — The Binding The Binding Hello, I own a The Binding that is covered by recall Z-1301-2018 from The Binding. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
