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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 23, 2024 · Data as of Sep 19, 5:48 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.