Class 2 Device Recall Aquios CL Flow Cytometer

• Date Initiated by Firm: September 06, 2016
• Date Posted: September 28, 2016
• Recall Status: Terminated on August 07, 2017
• Recall Number: Z-2900-2016
• Recall Event ID: 75111
• 510(K)Number: K141932
• Product Classification: Flow cytometric reagents and accessories. - Product Code OYE
• 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.
• Code Information: AY20032 AZ19046 AZ12030 AY51072 AZ19047 AZ15044 AY47071 AZ15038 AY47063 AZ12033 AZ19052 AY51075 AY03004 AZ12027 AY25038
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• Manufacturer 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.
• FDA Determined Cause: Software Design Change
• Action: 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.
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OYE