The Binding Site Group, Ltd. recalls Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of…

Recall date

January 4, 2018

Source

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

Recall number

Z-0553-2018

FDA classification

Class II

Brand / firm

The Binding Site Group, Ltd.

Sold / distributed

US Distribution was made to CA. There was no foreign/military/government distribution.

Why it was recalled

The low and high controls for the product are returning results above the 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

Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings