Becton, Dickinson and Company, BD Biosciences recalls BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics

Recall date

March 18, 2016

Source

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

Recall number

Z-1390-2016

FDA classification

Class III

Brand / firm

Becton, Dickinson and Company, BD Biosciences

Sold / distributed

Worldwide Distribution - US Distribution to the states of : CT, MN, FL, NY, CA, MA, DC, UT, VA and IN., and to the countries of : Belgium, Brazil, Canada, China, India, Japan, Korea, Singapore and Taiwan.

Why it was recalled

The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect storage conditions. The labels on the reagent as well as the Instructions for Use are correct.

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

What was recalled

BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics