AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.
Recall
- Recall Number
- Z-2900-2016
- Event Number
- 75111
- Firm
- Beckman Coulter Inc.
- FEI Number
- 2050012
- Product Code
- OYE
- Status
- Terminated
- Root Cause
- Software Design Change
- Initiated
- September 6, 2016
- Posted
- September 28, 2016
- Terminated
- August 7, 2017
- Address
- 250 S Kraemer Blvd, Brea, CA, 92821-6232
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.
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.
An Urgent Medical Device Recall letter dated 9/6/16 was sent to customers to inform them that the use of Positions 9 and 10 of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe. The letter informs the customers of the impact of the recall, action to be taken, and the resolution by Beckman Coulter. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding this notice, are instructed to contact Customer Support Center: http://www.beckmancoulter.com/customersupport/support; call 1-800-369-0333 in the US and Canada; outside the US and Canada, contact their local Beckman Coulter Representative.
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
148 units total (12 units in US)