Becton, Dickinson and Company, BD Biosciences recalls FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.

Recall date

December 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0628-2016

FDA classification

Class III

Brand / firm

Becton, Dickinson and Company, BD Biosciences

Sold / distributed

Nationwide Distribution

Why it was recalled

Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation. The functional degradation has the effect of reducing the percent positive from 100% down to approximately 87%.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.