Binding Site Human IgM Kit (for Spaplus) recalled

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

U.S.: IL, WV, NE, SD, NY, IN, WA, MD, NJ, PA, NC, AR, FL, VA

ArkansasFloridaIllinoisIndianaMarylandNorth CarolinaNebraskaNew JerseyNew YorkPennsylvaniaSouth DakotaVirginiaWashingtonWest Virginia