FDA-Device2021-02-10Class II
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
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.
Sold states
U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided
Affected count
213 kits in the U.S.
Manufactured in
8 Calthorpe Road, Birmingham, United Kingdom
Products
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0943-2021More The Binding Site Group, Ltd. recalls
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