FDA-Device2021-12-01Class II
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
The Binding Site Group, Ltd.
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.
Sold states
U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada
Affected count
2,254 kits
Manufactured in
8 Calthorpe Road, Birmingham, United Kingdom
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0274-2022Don't want to check this manually?
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