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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 antiser
Recalled December 19, 2018 · FDA recall Z-0604-2019 · The Binding Site Group
Hazard
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. · FDA Class II
Units
60
Sold at
U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,
Description
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.
Product
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.
Manufacturer(s)
The Binding Site Group, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →