Class 2 Device Recall iChem VELOCITY Automated Urine Chemistry System

• Date Initiated by Firm: March 29, 2018
• Date Posted: April 27, 2018
• Recall Status: Terminated on June 27, 2019
• Recall Number: Z-1894-2018
• Recall Event ID: 79895
• 510(K)Number: K101852
• Product Classification: Automated urinalysis system - Product Code KQO
• Product: iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in a iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems.
• Code Information: Catalog 700-7176-001 - Serial numbers V04494 and CV04015; Catalog 700-7177-001 - Serial numbers CV04012, CV04013, CV04014, and CV04017.
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Aruna Badiga, Ph. D.; 305-380-4189
• Manufacturer Reason for Recall: The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
• FDA Determined Cause: Process control
• Action: The recalling firm, Beckman Coulter/IRIS, sent an "URGENT MEDICAL DEVICE RECALL" letter dated dated 3/26/2018 via email on 3/29/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: -Follow the on-board strip stability claims per Table 1 to determine the frequency at which the strips need to be changed. -Whenever the Strip Provider Module is accessed (i.e., opened or when loading strips), remove and discard the remaining on-board strips and desiccant before replenishing. -It is suggested that for the tests performed since the installation of the iChemVELOCITY/SPM housing assembly, consult with your Laboratory Director to determine whether a retrospective review of results is clinically warranted. -Complete and return the CUSTOMER RESPONSE FORM within 10 days by email to: Regulatory.Notifications@beckman.com, Please include FA-33476 iChemVELOCITY Automated Urine Chemistry System in e-mail subject field or by 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. -Beckman Coulter will contact you by phone to schedule a site visit for replacing the SPM on your instrument. -Beckman Coulter will be implementing process improvements to prevent this issue from recurring. If you have any questions regarding this notice, please contact: - From our website: http://www.beckmancoulter.com - By phone: call 800-854-3633 in the United States and Canada. -Outside the United States and Canada, contact your local Beckman Coulter representative.
• Quantity in Commerce: 6 devices
• Distribution: US Distribution to states of: AL, IA, GA, and FL.
• 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