The Binding Site Group recalls Rheumatoid Factor (RF) Kit for SPAPLUS analyser due to low and high controls returning results above assigned values. This may affect rheumatoid arthritis testing accuracy.
The low and high controls for the product are returning results above the assigned values.
The Binding Site Group recalls their Rheumatoid Factor (RF) Kit for SPAPLUS analyser because the low and high control samples give results higher than expected. This could lead to inaccurate rheumatoid arthritis test results if used without correction.
The low and high control samples in the kit produce results that exceed the expected values. This could cause inaccurate measurements of rheumatoid factor in serum, potentially leading to incorrect diagnosis or treatment decisions.
People using this kit for rheumatoid arthritis testing may be affected. Those with rheumatoid arthritis who rely on accurate lab results are most at risk.
Check for the product name 'Rheumatoid Factor (RF) Kit for SPAPLUS', product number LK151.S.A, and lot number 416595 (expired 31/03/2018).
Verify the product number LK151.S.A and lot number 416595 on the kit label.
The low and high controls for the product are returning results above the assigned values, which could lead to inaccurate rheumatoid arthritis test results.
Using this kit may result in inaccurate measurements of rheumatoid factor in serum, potentially affecting diagnosis decisions.
The recall record does not specify a remedy, so contact The Binding Site Group for guidance.
We’ve drafted a message you can send The Binding Site Group to request your refund or repair — edit it as you like.
Subject: Recall Z-0553-2018 — The Binding Site Group The Binding Site Group Hello, I own a The Binding Site Group that is covered by recall Z-0553-2018 from The Binding Site Group. 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.
