Becton, Dickinson and Company, BD Biosciences recalls BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes

Recall date

August 19, 2019

Source

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

Recall number

Z-0067-2020

FDA classification

Class II

Brand / firm

Becton, Dickinson and Company, BD Biosciences

Sold / distributed

U.S.: CA, KS, NJ, MI, NY, PA, IL, IN, VA, WA, MD, IA, OK, RI, FL, CO, OH, TX, TN, GA, MO, MN, HI, VT, MA, NE. O.U.S. (Foreign): Germany, Italy, South Korea, Japan, United Kingdom, Poland, France, Belgium, Canada, Latvia, India, Taiwan, Ireland, Algeria, Israel, Iraq, Netherlands, Malaysia, Australi…

Why it was 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.

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 FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes