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FDAOctober 15, 2021device

Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S

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

The hazard

Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.

What to do

FDA enforcement status: Terminated

Brands named

binding sitebinding

UPCs

0505170000647705051700012201

Recall history

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

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