Class 2 Device Recall iChemVELOCITY

• Date Initiated by Firm: March 30, 2020
• Date Posted: May 09, 2020
• Recall Status: Terminated on August 31, 2023
• Recall Number: Z-1944-2020
• Recall Event ID: 85423
• 510(K)Number: K101852
• Product Classification: Automated urinalysis system - Product Code KQO
• Product: iChem¿VELOCITY Urine Chemistry System-
• Code Information: Catalog #700-7176-001 and #700-7177-001, All part numbers
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Customer Support Center; 714-961-5321
• Manufacturer Reason for Recall: A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computers metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the devices CD-ROM.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 03/25/2020 Beckman Coulter Inc. sent out Urgent Medical Device Alert identifying the problem, the circumstances in which it can occur, the actions that should be taken by the customer/user in order to prevent risks to patients or users, and the actions planned by Beckman Coulter to correct the problem. PRODUCTS: Products installed between July of 2012 and December of 2014 are in scope of this field corrective action and can be identified by the name of the Product (all part numbers) that were installed in the time frames noted. ACTION TO BE TAKEN BY CUSTOMER/USER: If flames and or smoke be detected within the computer the customers/users should; follow laboratorys safety guidelines, contact Beckman Coulter by phone: call 800-526-7694 in the United States and Canada or if outside the United States and Canada, contact Beckman Coulter hotline or the local Beckman Coulter representative, and Follow Standard Operating Procedures (SOP) for Instrument backup testing methodology. This information should be communicated to all laboratory staff and retained as part of lab quality system documentation. Customers are asked to complete the Notification Response Form either electronically or manually depending on the method the notice was received. ACTIONS PLANNED BY BECKMAN COULTER: A Beckman Coulter service provider will proactively schedule a service visit to inspect the PC6 computer and replace the affected cable, if necessary. Additional potentially affected customers will be notified of the issue via Updated Urgent Medical Device Recall letter that will be sent during the week of 10/26/2020 via mail and/or e-mail. Note: Customers that received the initial letter but have any of the additional potentially affected devices will be re-notified of the issue.
• Quantity in Commerce: 1557 units
• Distribution: US Distribution: Nationwide Foreign Distribution: Worldwide
• 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 = KQO and Original Applicant = IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I