FDA-Device2016-10-05Class II
AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.
Beckman Coulter Inc.
Hazard
Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe.
Sold states
US: IL, PA, NY, GA, WA, FL, SC. Affected geographies: Angola, Australia, Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Israel, Italy, Malaysia, Nambia, Netherlands, Panama, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Uganda, United Kingdom and Zambia
Affected count
148 units total (12 units in US)
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2900-2016Don't want to check this manually?
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