Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems Recalled by The Binding Site Group, Ltd. Due to The high and low level "Quality Controls" demonstrate...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact The Binding Site Group, Ltd. directly.
Affected Products
FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096
Why Was This Recalled?
The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About The Binding Site Group, Ltd.
The Binding Site Group, Ltd. has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report