Beckman Coulter Inc. recalls 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cyto…

Recall date

January 12, 2018

Source

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

Recall number

Z-0471-2019

FDA classification

Class I

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Worldwide distribution. US Nationwide including Puerto Rico. OUS: FC 500: Japan, South Korea, China, Italy, Spain, United Kingdom, Germany, Bangladesh, Czech Republic, France, Pakistan, India, South Africa, Austria, Saudi Arabia, Algeria, Turkey, Belgium, Netherlands, Bulgaria, Sweden, Australia, H…

Why it was recalled

A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics