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
Product summary
- 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
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.