The Binding Site Group recalls Freelite Human Lambda Free Kit (REF LK018.S) due to calibration issues that may cause inaccurate test results. Affected units include specific lot numbers and model numbers.
Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.
The Binding Site Group is recalling Freelite Human Lambda Free Kit (for use on SPAPLUS) because calibration problems could lead to inaccurate test results. This affects specific model numbers and lot numbers, and users should check their product details.
The kit's calibration curves may produce higher activity than expected, and there could be a decrease in separation between calibrator points 5 and 6. This issue might worsen if calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.
Users of the Freelite Human Lambda Free Kit for SPAPLUS testing are affected. Those with the specific model numbers LK018.S and LK018.10S and lot numbers 472776 or 472664 are most at risk.
Check for model numbers LK018.S or LK018.10S and lot numbers 472776 or 472664 on the product packaging or label.
Identify your model number and lot number to confirm if you have an affected unit.
The recalled model numbers are LK018.S and LK018.10S.
Lot numbers 472776 and 472664 are affected.
The recall does not require immediate stop use; check your product details to see if you are affected.
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-0274-2022 — The Binding Site Group The Binding Site Group Hello, I own a The Binding Site Group that is covered by recall Z-0274-2022 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.
