Binding Site Human IgM Kit Recalled for Calibration Curve Validation Issues
The Binding Site Group is recalling 60 units of Human IgM Kits due to challenges in validating the calibration curve, indicated by control values outside specified ranges.
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, but the source text describes a technical validation issue (control values outside ranges) without reporting any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
The Binding Site Group, Ltd. is recalling 60 units of the Binding Site Human IgM Kit (for SPAPLUS), Reference NK012.S, Lot 413849. The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators, and two controls based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.
The recall was initiated because the firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This issue is indicated by kit control values reporting outside the specified ranges. The agency classifies this as a Class II recall.
The affected products were distributed in the United States to the states of California, Illinois, Pennsylvania, Florida, Nebraska, Washington, Indiana, New York, South Dakota, and Virginia. Customers should contact the recalling firm for advice regarding the validation challenges.
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
- 60
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 413849
Distribution
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