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 FACSLyric Flow Cytometer Recalled by Becton, Dickinson and Company, BD Biosciences Due to Flow cytometers, when used with specific tubes may...

Date: August 19, 2019
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 FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes

Quantity: 21

Why Was This Recalled?

Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

Where Was This Sold?

This product was distributed to 26 states: CA, CO, FL, GA, HI, IL, IN, IA, KS, MD, MA, MI, MN, MO, NE, NJ, NY, OH, OK, PA, RI, TN, TX, VT, VA, WA

Affected (26 states)Not affected

About Becton, Dickinson and Company, BD Biosciences

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

Related Recalls

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