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The Binding Site Group, Ltd. recalls Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
Recalled February 10, 2021 · FDA recall Z-0943-2021 · The Binding Site Group
Hazard
Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values. · FDA Class II
Units
213 kits in the U.S.
Sold at
U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided
Description
Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.
Product
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
Manufacturer(s)
The Binding Site Group, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →