Becton, Dickinson and Company, BD Bio Sciences recalls BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD

Recall date

July 8, 2025

Source

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

Recall number

Z-2237-2025

FDA classification

Class II

Brand / firm

Becton, Dickinson and Company, BD Bio Sciences

Sold / distributed

Worldwide - US Nationwide distribution in the states of Tennessee, New York, Massachusetts and the countries of Argentina, Belgium, Botswana, Brazil, Canada, France, Germany, Lithuania, Peru, Philippines, United Kingdom.

Why it was recalled

Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.

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 Controls, 30 Test - REF: 664343, RxOnly, IVD