The Binding Site Group, Ltd. recalls C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,

Recall date

April 25, 2019

Source

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

Recall number

Z-1619-2020

FDA classification

Class II

Brand / firm

The Binding Site Group, Ltd.

Sold / distributed

U.S.: FL

Why it was recalled

A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected

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

What was recalled

C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,