The Binding Site Group, Ltd. recalls FREELITE Human Kappa Free Kit for use on the Roche cobas c S
Recalled Product
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
Hazard / Issue
The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
Issued by
FDA
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