Lower riskMedical device recall · FDA · Published November 18, 2020
Optil: Freelite Mx Kappa Free Kit recall due to quality control bias
The Binding Site Group recalls Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A due to positive bias in quality control measurements. Affected units have specific model and lot numbers.
Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.
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Contact the company
📍Recalling firmThe Binding Site Group, Ltd.8 Calthorpe Road · Birmingham, United Kingdom
✎ GovInfoNow plain-language explainer
The Binding Site Group is recalling their Optilite Freelite Mx Kappa Free Kit (model LK016.M.OPT.A) because quality control measurements show positive bias. This could lead to inaccurate results in testing, but the recall does not involve immediate safety risks. Read more at govinfonow.com/recall/63869-optil-freelite-mx-kappa-free-kit-recall-due-to-quality.
“Optil: Freelite Mx Kappa Free Kit recall due to quality control bias.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63869-optil-freelite-mx-kappa-free-kit-recall-due-to-quality. Based on FDA recall #Z-0943-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0943-2021%22&limit=1).
The Food and Drug Administration announced on Nov. 18, 2020, that The Binding Site Group, Ltd. voluntarily recalled the Optilite Freelite Mx Kappa Free Kit due to a positive bias in quality control levels. The agency classified the recall as Class II.
How to tell if you have it
Brand: The Binding Site Group
Product: Optilite Freelite Mx Kappa Free Kit
Reference Number: LK016.M.OPT.A
Model Number: LK016.M.OPT.A
UDI: 05051700019866
Lot Number: 454763
The hazard
The high and low level controls demonstrate a positive bias compared to assigned values, according to customer complaints. This issue impacts quality control for the device.
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), Freelite Human Lambda Free Kit (Oct. 15, 2021), and FREELITE Human Kappa Free Kit (May 20, 2021).
How to tell if you have this one
Check for the model number LK016.M.OPT.A on the kit. The lot number 454763 and unique identifier 05051700019866 are also associated with this recall.
Brand
The Binding Site Group
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the model number LK016.M.OPT.A and lot number 454763 on the kit.
Where it went and when
Where it was distributed
Distributed in 10 states.
Listed by the agency
Not listed
FDA distribution: “U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Colorado, Florida, Iowa, Massachusetts, New Jersey, New York, North Carolina, Ohio, South Dakota, Utah.
Recall timeline
FDA terminated this recall 4.1 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-0943-2021 (November 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0943-2021 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.