Binding Site recalls Optilite Freelite Mx Kappa Free Kits for quality control bias
The Binding Site Group is recalling 213 Optilite Freelite Mx Kappa Free Kits in the U.S. due to customer complaints of positive bias affecting quality control.
What this means for you
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 does not report any hospitalizations, injuries, or illnesses. The hazard is a quality control issue (positive bias) rather than a direct physical safety risk like fire or choking, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Binding Site Group, Ltd. is recalling 213 units of the Optilite Freelite Mx Kappa Free Kit (REF LK016.M.OPT.A) in the United States. The affected product is identified by Model Number LK016.M.OPT.A, UDI 05051700019866, and Lot Number 454763.
The recall was initiated due to customer complaints regarding positive bias that impacts quality control. Specifically, the high and low level controls are demonstrating a positive bias compared to their assigned values. This issue may affect the accuracy of the test results.
The affected kits were distributed in Colorado, Florida, Iowa, Massachusetts, North Carolina, New Jersey, New York, Ohio, South Dakota, and Utah. The source text does not specify the actions consumers or healthcare providers should take, such as whether to stop using the product or contact the manufacturer for a replacement.
The recalled product
- Product
- Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
- Manufacturer
- The Binding Site Group, Ltd.
- Hazard
- Affected units
- 213
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)
- Model Number: LK016.M.OPT.A UDI: 05051700019866 Lot Number: 454763
Distribution
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