Freelite Human Lambda Free Kit Recalled for Calibration Curve Inaccuracy
The Binding Site Group recalled 2,254 Freelite Human Lambda Free Kits due to calibration curve issues that may produce higher-than-expected activity readings and affect measurement accuracy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a functional calibration issue that could lead to inaccurate diagnostic test results. No illnesses or injuries reported; this represents a risk-of-harm scenario per the recall severity rubric.
Plain-English summary
The Binding Site Group, Ltd. is recalling 2,254 units of the Freelite Human Lambda Free Kit for use on the SPAPLUS analyzer. The affected products include Model LK018.S (Lot 472776) and Model LK018.10S (Lot 472664).
The kits have calibration curve issues. Specifically, the calibration curves produce higher activity readings than routinely expected. Additionally, there is a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated when calibrator 6 activity reaches the optical ceiling of the analyzer.
The affected kits were distributed in the United States to facilities in California, Colorado, Florida, Illinois, Indiana, Kentucky, Louisiana, Michigan, New York, Oklahoma, South Dakota, Texas, and Virginia, as well as in Canada.
Laboratories receiving affected kits should verify the lot numbers against those listed and contact The Binding Site Group for instructions on return or replacement. The FDA classified this as a Class II recall.
The recalled product
- Product
- Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
- Manufacturer
- The Binding Site Group, Ltd.
- Hazard
- calibration-error
- measurement-inaccuracy
Distribution
Distributed in 13 states:
- CA
- CO
- FL
- IL
- IN
- KY
- LA
- MI
- NY
- OK
- SD
- TX
- VA
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