BD Biosciences, Systems & Reagents recalls BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,…

Recall date

June 15, 2015

Source

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

Recall number

Z-2090-2015

FDA classification

Class III

Brand / firm

BD Biosciences, Systems & Reagents

Sold / distributed

Nationwide Distribution

Why it was recalled

Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50).

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.