Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Binding Site Human IgM Kit (for SPAPLUS) Recalled by The Binding Site Group, Ltd. Due to After running the calibration curve, the recovery of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact The Binding Site Group, Ltd. directly.
Affected Products
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.
Quantity: 108
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 14 states: AR, FL, IL, IN, MD, NE, NJ, NY, NC, PA, SD, VA, WA, WV
About The Binding Site Group, Ltd.
The Binding Site Group, Ltd. has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report