medical Class II Updated 2021-12-01

The Binding Site Group, Ltd. recalls Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Affected States: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX, VA

Lot/Code Info: Model Number: LK018.S UDI Code: 05051700006477 Lot Number: 472776 Model Number:LK018.10S UDI Code: 05051700012201 Lot Number: 472664

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