The Binding Site recalls FREELITE Human Kappa Free Kit for 10% positive bias in Roche
The Binding Site recalls FREELITE Human Kappa Free Kit for Roche cobas systems due to 10% positive bias in quality controls. Affected kits may give false high results. No remedy specified in recall notice.
Recall notice
The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
Contact the company
What happened, in plain English
The Binding Site recalls FREELITE Human Kappa Free Kit for Roche cobas systems because quality controls show a 10% positive bias compared to assigned values. This could lead to false high results in test readings. The recall does not include a remedy. Read more at govinfonow.com/recall/62503-the-binding-site-recalls-freelite-human-kappa-free-kit-for.
Source Summary by GovInfoNow · govinfonow.com/recall/62503-the-binding-site-recalls-freelite-human-kappa-free-kit-for · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2030-2021
Cite this page
“The Binding Site recalls FREELITE Human Kappa Free Kit for 10% positive bias in Roche.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62503-the-binding-site-recalls-freelite-human-kappa-free-kit-for. Based on FDA recall #Z-2030-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2030-2021%22&limit=1).
Why it’s dangerous
The quality controls in the kit show a 10% positive bias compared to assigned values. This means the kit may produce test results that are too high, potentially leading to incorrect diagnoses or treatment decisions.
Who’s affected
Users of the FREELITE Human Kappa Free Kit for Roche cobas c Systems are affected. Laboratory staff and healthcare providers who use this kit for testing are most at risk.
How to tell if you have this one
Check for the kit's lot numbers: 487719 (expiring July 31, 2022), 480133 (expiring September 30, 2022), or 457890 (expiring September 30, 2022). The kit is labeled as FREELITE Human Kappa Free Kit for Roche cobas c Systems.
- Brand
The Binding Site- Category
Medical device
What to do — step by step
Check Kit Lot Numbers
Look for lot numbers 487719, 480133, or 457890 on the kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 19 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of CA, GA, FL, MA, MO, MI, WA, NY, PA, MN, AL, MD, OK, NE, IN, ID, OH, TX, HI, DC and the countries of Canada, Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Czech…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, District of Columbia, Florida, Georgia, Hawaii, Idaho, Indiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, Texas, Washington.
Recall timeline
FDA terminated this recall 3.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-2030-2021 (May 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2030-2021 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.