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.
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.
The high and low level controls in the kit show positive bias compared to assigned values. This means the measurements may be higher than they should be, leading to inaccurate quality control results. However, this does not pose a direct safety hazard.
Users of the Optilite Freelite Mx Kappa Free Kit model LK016.M.OPT.A are affected. Laboratory or clinical staff who rely on this kit for quality control testing are most at risk.
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.
Verify the model number LK016.M.OPT.A and lot number 454763 on the kit.
No, this recall is for quality control issues, not safety risks. The hazard does not involve physical harm.
The recall does not specify a remedy, so no action is required beyond checking if you have the affected model.
Look for the model number LK016.M.OPT.A and lot number 454763 on the kit.
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-0943-2021 — The Binding Site Group The Binding Site Group Hello, I own a The Binding Site Group that is covered by recall Z-0943-2021 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.
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.
