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FDAOctober 16, 2014device

MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.

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

The hazard

Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.

What to do

FDA enforcement status: Terminated

Brands named

diagnostic hybridsdiagnostic

Recall history

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

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