medical Class II Updated 2018-12-19

The Binding Site Group, Ltd. recalls Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S Th

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Affected States: CA, IL, PA, FL, NE, WA, IN, NY, SD, VA
Lot/Code Info: Lot 413849
View official government recall

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