The Binding Site Group, Ltd. recalls Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitati…

Recall date

February 19, 2019

Source

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

Recall number

Z-0671-2020

FDA classification

Class II

Brand / firm

The Binding Site Group, Ltd.

Sold / distributed

US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS

Why it was recalled

Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits

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

What was recalled

Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.