Class 2 Device Recall AQUIOS CL Flow Cytometer System

• Date Initiated by Firm: August 21, 2017
• Create Date: September 19, 2017
• Recall Status: Terminated on September 27, 2023
• Recall Number: Z-3135-2017
• Recall Event ID: 77997
• 510(K)Number: K141932
• Product Classification: Flow cytometric reagents and accessories. - Product Code OYE
• Product: AQUIOS CL Flow Cytometer System; ; The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
• Code Information: All software versions.; Serial numbers - BA30048, AY20032, BA01007, AZ19046, AZ12030, BA25046, BA05011, AY51072, BA01002, AZ15044, BA30049, BA30050, BA05015, AZ19047, BA18029, AY47071, AZ15038, BA23036, BA23035, AZ23058, AZ20057, AY47063, BA15024, BA15023, AZ45080, BA01010, AZ25070, AZ32071, AZ12033, AZ25065, AZ25068, AY51075, AZ19052, BA15025
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Customer Service; 800-369-0333
• Manufacturer Reason for Recall: Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm, Beckman Coulter, sent an "URGENT MEDICAL DEVICE RECALL" letter dated August 16, 2017 to the affected customers via email, mail, and phone during the week of August 21, 2017. The letter described the product, problem and actions to be taken. The customers are instructed to follow instructions provided in the letter and complete and return the Customer Response Form within 10 days via Fax to: (786)-639-7500 /7501 /7502 /7504; mail to: Beckman Coulter, Inc.,- Attn: Regulatory Affairs Mail Code 31-B06; 11800 S.W. 147th Avenue; P O BOX 169015, Miami, FL 33116-9015 or email (if received electronically) at: Regulatory.Notifications@beckmancoulter.com -include in subject field: FA-31696 AQUIOS CL August 2017. If you have any questions regarding this notification, please contact: ¿ From our website: http://www.beckmancoulter.com ¿ By phone: call 800-369-0333 in the United States and Canada. ¿ By email: LScustomerLetter@Beckman.com ¿ Outside the United States and Canada, contact your local Beckman Coulter representative.
• Quantity in Commerce: 213 units (34 units in the US)
• Distribution: Worldwide Distribution: United States (nationwide) and countries of: Angola, Australia, Botswana, Canada, Chile, Columbia, Ghana, Israel, Malaysia, Namibia, Pakistan, Panama, South Africa, Uganda, France, Switzerland, Poland, Portugal, Germany, Belgium, Finland, Czech Republic, Denmark, Netherland, Turkey, Spain, Great Britain, Romania, Brazil, Italy, Sweden, Ghana, Colombia, Lesotho 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 and Original Applicant = BECKMAN COULTER, INC.