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.
The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
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.
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.
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.
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.
Look for lot numbers 487719, 480133, or 457890 on the kit packaging.
The recall notice does not specify any remedy.
It means the quality controls in the kit may show test results that are 10% higher than expected, potentially leading to false high readings.
Check the lot numbers on the kit: 487719 (expiring July 31, 2022), 480133 (expiring September 30, 2022), or 457890 (expiring September 30, 2022).
We’ve drafted a message you can send The Binding Site to request your refund or repair — edit it as you like.
Subject: Recall Z-2030-2021 — The Binding Site The Binding Site Hello, I own a The Binding Site that is covered by recall Z-2030-2021 from The Binding Site. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
