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
Check against the official notice below — it lists the full affected range.
The Binding Site Group, Ltd. is recalling Freelite Human Lambda Free Kits designed for use on the SPAPLUS analyzer. The kits have calibration curve issues that produce higher activity readings than expected and may reduce the separation between calibrator points 5 and 6, with potential worsening when calibrator 6 activity reaches the analyzer's optical ceiling. The recall affects 2,254 kits distributed across 13 U.S. states (California, Colorado, Florida, Illinois, Indiana, Kentucky, Louisiana, Michigan, New York, Oklahoma, South Dakota, Texas, and Virginia) as well as Canada.
The affected kits include two model numbers: LK018.S (Lot Number 472776) and LK018.10S (Lot Number 472664). The recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.
Reason for recall: Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer. Distribution: U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada Quantity: 2,254 kits Lot/code info: Model Number: LK018.S UDI Code: 05051700006477 Lot Number: 472776 Model Number:LK018.10S UDI Code: 05051700012201 Lot Number: 472664
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.