medical Class II Updated 2018-11-28

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

After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve. Samples have been shown to be similarly affected.

Issued by

FDA

Affected States: IL, WV, NE, SD, NY, IN, WA, MD, NJ, PA, NC, AR, FL, VA
Lot/Code Info: Lot: 407483-1 and 407483-2
View official government recall

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