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The Binding Site Group, Ltd. recalls Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAP
Recalled December 1, 2021 · FDA recall Z-0274-2022 · The Binding Site Group
Hazard
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. · FDA Class II
Units
2,254 kits
Sold at
U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada
Description
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.
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(s)
The Binding Site Group, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →