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 Controls Recalled by Becton, Dickinson and Company, BD Bio Sciences Due to Control kits contain incorrect standard deviation (SD) values...

Date: July 8, 2025
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 Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD

Quantity: 10 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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