medical Class II Updated 2021-07-14

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

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 487719/ Exp: 31-Jul-2022, 480133/ Exp: 30-Sep-2022, Lot 457890/ Exp: 30-Sep-2022
View official government recall

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