Becton, Dickinson and Company, BD Biosciences recalls BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute coun…

Recall date

March 31, 2016

Source

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

Recall number

Z-1570-2016

FDA classification

Class II

Brand / firm

Becton, Dickinson and Company, BD Biosciences

Sold / distributed

Worldwide Distribution - US including MD, CA GA. WA. PA. CO. TN. FL. NC. DE. VA, CT, LA. NC, NY, OH, MN, NH and Internationally to China, Japan, and India.

Why it was recalled

One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this product is used.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.