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FDANovember 18, 2020device

Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

binding sitebinding

UPCs

05051700019866

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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