Binding Site Human IgM Kit Recalled for Reduced Accuracy
The Binding Site Group is recalling 108 units of Human IgM Kits due to reduced accuracy in control results and potential out-of-range readings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves reduced accuracy in test results without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
The Binding Site Group, Ltd. is recalling 108 units of the Binding Site Human IgM Kit (for SPAPLUS), Reference NK012.S. The affected lots are 407483-1 and 407483-2. The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators, and two controls, all containing sodium azide as a preservative.
The recall was initiated because the recovery of the IgM kit control results decreases after running the calibration curve, demonstrating a reduction in accuracy within the same day. Control results may be out of range one day after running the assay calibration curve, and samples have been shown to be similarly affected.
The affected units were distributed in Illinois, West Virginia, Nebraska, South Dakota, New York, Indiana, Washington, Maryland, New Jersey, Pennsylvania, North Carolina, Arkansas, Florida, and Virginia. Users should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- 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…
- Manufacturer
- The Binding Site Group, Ltd.
- Hazard
- Affected units
- 108
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 407483-1 and 407483-2
Distribution
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