Class 2 Device Recall iChem VELOCITY Urine Chemistry Strips

• Date Initiated by Firm: February 17, 2020
• Create Date: March 20, 2020
• Recall Status: Terminated on May 13, 2021
• Recall Number: Z-1535-2020
• Recall Event ID: 85047
• 510(K)Number: K101852
• Product Classification: Automated urinalysis system - Product Code KQO
• Product: iChemVELOCITY Strips, Catalog 800-7212
• Code Information: Catalog 800-7212, UDI 10837461002628; Lot 7212269M
• Recalling Firm/ Manufacturer: Beckman Coulter, Inc.; 11800 SW 147th Ave; Miami FL 33196-2500
• For Additional Information Contact: Roger Janczak; 305-380-4189
• Manufacturer Reason for Recall: The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
• FDA Determined Cause: Under Investigation by firm
• Action: An Urgent Medical Device Recall letter will be sent during the week of 02/17/2020 to the affected customers via email and mail. Customers are advised to discard the affected product and order a replacement from BEC.
• Quantity in Commerce: 10822 vials
• Distribution: Distribution in US including Puerto Rico, Canada, and Taiwan
• 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