The Binding Site Group, Ltd. recalls Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum…

Recall date

November 6, 2018

Source

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

Recall number

Z-0604-2019

FDA classification

Class II

Brand / firm

The Binding Site Group, Ltd.

Sold / distributed

U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,

Why it was recalled

Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.

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

What was recalled

Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.