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FDAJuly 29, 2019device

OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565

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

The hazard

There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.

What to do

FDA enforcement status: Terminated

Brands named

binding sitebinding

UPCs

05051700017565

Recall history

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

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