Optilite Freelite Lambda Free Kit Recalled for Inaccurate Test Results
The Binding Site Group is recalling 809 Optilite Freelite Lambda Free Kits because specific lots produce test results that are approximately 33% lower than expected.
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 describes a systematic measurement error (results 33% lower) rather than a direct physical hazard or reported illness. This aligns with the 'Moderate' criteria for low-risk contamination or labeling/measurement errors without reported injury.
Plain-English summary
The Binding Site Group, Ltd. is recalling 809 units of the Optilite Freelite Lambda Free Kit, a protein testing kit. The recall affects product codes LK018.OPT and LK018.OPT.A, specifically lot numbers 405566 and 405567.
The recall was initiated because batches with these lot numbers report Lambda Free Light Chain results greater than 114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. This discrepancy means that users switching to these specific kits will see lower test results, while switching back to other batches will cause results to shift upwards.
The affected kits were distributed in the United States to the states of Arkansas, Pennsylvania, Georgia, North Carolina, Kentucky, Virginia, and California. They were also distributed internationally to the United Kingdom, Germany, France, Italy, Spain, the Czech Republic, and Portugal. Users of these kits should be aware that the test results may be inaccurate and lower than expected for the specified range.
The recalled product
- Product
- Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
- Manufacturer
- The Binding Site Group, Ltd.
- Hazard
- Affected units
- 809
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 #405566
- 405567
Distribution
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