FDA-Device2021-02-10Class II
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
The Binding Site Group, Ltd.
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-0943-2021Don't want to check this manually?
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