PlainRecalls
FDA Devices Moderate Class II Terminated

AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.

Reported: October 5, 2016 Initiated: September 6, 2016 #Z-2900-2016

Product Description

AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.

Reason for Recall

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.

Details

Recalling Firm
Beckman Coulter Inc.
Units Affected
148 units total (12 units in US)
Distribution
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
Location
Brea, CA

Frequently Asked Questions

What product was recalled?
AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.. Recalled by Beckman Coulter Inc.. Units affected: 148 units total (12 units in US).
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 5, 2016. Severity: Moderate. Recall number: Z-2900-2016.