Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BD FACSDuet Premium Sample Preparation System Recalled by Becton, Dickinson and Company, BD Bio Sciences Due to Sample preparation system with software may cause: 1)...

Date: August 12, 2024
Company: Becton, Dickinson and Company, BD Bio Sciences
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Becton, Dickinson and Company, BD Bio Sciences directly.

Affected Products

BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.

Quantity: 130

Why Was This Recalled?

Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy.

Where Was This Sold?

This product was distributed to 13 states: AK, CA, ID, MD, MA, MI, MN, NJ, TN, TX, UT, VA, WI

Affected (13 states)Not affected

About Becton, Dickinson and Company, BD Bio Sciences

Becton, Dickinson and Company, BD Bio Sciences has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report