The Binding Site Group, Ltd. recalls FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas…

Recall date

May 20, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2030-2021

FDA classification

Class II

Brand / firm

The Binding Site Group, Ltd.

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of CA, GA, FL, MA, MO, MI, WA, NY, PA, MN, AL, MD, OK, NE, IN, ID, OH, TX, HI, DC and the countries of Canada, Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Italy, Luxembour…

Why it was recalled

The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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