Lower riskMedical device recall · FDA · Published October 15, 2021
Freelite Human Lambda Free Kit Recall: Calibration Issues May Cause Inaccurate Results
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.
Take action
Contact the company
📍Recalling firmThe Binding Site Group, Ltd.8 Calthorpe Road · Birmingham, United Kingdom
“Freelite Human Lambda Free Kit Recall: Calibration Issues May Cause Inaccurate Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61673-freelite-human-lambda-free-kit-recall-calibration-issues-may-cause. Based on FDA recall #Z-0274-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0274-2022%22&limit=1).
The Binding Site Group, Ltd. recalled Freelite Human Lambda Free Kits on Oct. 15, 2021, due to calibration curve errors that may produce higher activity than expected, the FDA said in a Class II recall.
How to tell if you have it
Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S, Lot Number: 472776
Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S, Lot Number: 472664
The hazard
The recall cites calibration curves producing higher activity than routinely expected and a potential decrease in separation between calibrator points 5 and 6, which can be exacerbated when calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.
Context
GovInfoNow's records show The Binding Site Group, Ltd. has had 15 other recalls on record since Aug. 23, 2017. Other recent recalls of similar products include EXENT Analyser Software Version 1.0.20 (April 16, 2026) and Freelite Human Kappa Free Kit (May 20, 2021).
How to tell if you have this one
Check for model numbers LK018.S or LK018.10S and lot numbers 472776 or 472664 on the product packaging or label.
Brand
The Binding Site Group
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify your model number and lot number to confirm if you have an affected unit.
Where it went and when
Where it was distributed
Distributed in 13 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Florida, Illinois, Indiana, Kentucky, Louisiana, Michigan, New York, Oklahoma, South Dakota, Texas, Virginia.
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0274-2022 (October 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0274-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.