Binding Site Freelite Human Lambda Free SPAPlus Kit Recalled for Calibration Drift
The Binding Site Group is recalling 1,002 units of the Freelite Human Lambda Free SPAPlus Kit because calibration curve activity increased over time.
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. The source text does not report any hospitalizations, injuries, or illnesses, and the hazard is a technical calibration drift rather than a direct physical injury risk, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
The Binding Site Group, Ltd. is recalling 1,002 units of the Human Lambda Free SPAPlus Kit (Product Code: LK018.S). The Freelite kit is used to aid in the detection and monitoring of Multiple Myeloma and related diseases.
The recall was initiated because calibration curve activity has increased over time in the affected kit lots. The specific lots involved are #323278 and #327963.
The affected products were distributed in the United States to California, Texas, Hawaii, Georgia, Pennsylvania, Utah, New York, Oklahoma, Idaho, Massachusetts, and Arizona. They were also distributed internationally to Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, and Spain. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these recalled units.
The recalled product
- Product
- Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
- Manufacturer
- The Binding Site Group, Ltd.
- Hazard
- Affected units
- 1,002
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 (2)
- Lot #323278
- 327963
Distribution
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