Beckman Coulter Inc. recalls AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland.…

Recall date

October 2, 2017

Source

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

Recall number

Z-0091-2018

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Worldwide Distribution - US Distribution to the states of : AZ, CA, CO, FL, GA, IL, IN, KS, NC, NY, OR, PA, SC, TX, and WA, including Puerto Rico and government distribution, and to the countries of : Canada, Angola, Australia, Belgium, Botswana, Brazil, Chile, Colombia, Czech Republic, Denmark, Fi…

Why it was recalled

The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagents and software package: AQUIOS Tetra-1 Panel monoclonal antibody reagents, AQUIOS Tetra-2+ Panel monoclonal antibody reagents, and AQUIOS CL Flow Cytometry Software.