Reported Feb 10, 2021 · Terminated
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
The Binding Site Group, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Binding Site Group, Ltd. · 8 Calthorpe Road · Birmingham · N/A
Is this the product you have?
- Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
- Lot codes and dates
- Model NumberLK016.M.OPT
- A UDI05051700019866
- Lot Number454763
- Amount recalled
- 213 kits in the U.S.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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