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 Trucount Absolute Counting Tubes: Model number: 340334 IVD Recalled by Becton, Dickinson and Company, BD Biosciences Due to One lot of lot of BD Trucount tubes...

Date: March 31, 2016
Company: Becton, Dickinson and Company, BD Biosciences
Status: Terminated
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 Biosciences directly.

Affected Products

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.

Quantity: 1743; 467 US and 1276 International

Why Was This 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.

Where Was This Sold?

This product was distributed to 17 states: CA, CO, CT, DE, FL, GA, LA, MD, MN, NH, NY, NC, OH, PA, TN, VA, WA

Affected (17 states)Not affected

About Becton, Dickinson and Company, BD Biosciences

Becton, Dickinson and Company, BD Biosciences has 35 total recalls tracked by RecallDetector.

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