Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2900-2016

September 06, 2016

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 75111
Status
Terminated
Classification
Class II
Quantity
148 units total (12 units in US)
Official record key
device-enforcement:Z-2900-2016

Official wording

Reason: 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.

Code information: AY20032 AZ19046 AZ12030 AY51072 AZ19047 AZ15044 AY47071 AZ15038 AY47063 AZ12033 AZ19052 AY51075 AY03004 AZ12027 AY25038

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.