Class 2 Device Recall iQ200 Series Urine Microscopy Analyzer with Barcode Reader

• Date Initiated by Firm: November 10, 2017
• Create Date: April 12, 2018
• Recall Status: Terminated on December 21, 2022
• Recall Number: Z-1366-2018
• Recall Event ID: 79368
• 510(K)Number: K022774
• Product Classification: Automated urinalysis system - Product Code KQO
• Product: iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157
• Code Information: All iQ200 Series in the field with barcode reader model NFT-2100
• FEI Number: 2050012
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: 469-961-4941
• Manufacturer Reason for Recall: iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria.
• FDA Determined Cause: Device Design
• Action: An urgent medical device recall letter, dated 11/10/2017, was sent to customers informing them that Beckman Coulter was initiating a field action for the iQ200 Series Urine Microscopy Analyzer with Barcode Reader, which may fail to read urine sample dilution barcode labels instead defaulting to no dilution, dilution factor of 1:1. In addition, this product may also fail to read urine sample dilution barcode labels, when the rack is rejected, leading to no results. Customers were informed of the issue, impact, action, and that the resolution was being investigated. Customers were instructed to respond within 10 days: electronically via email or manually by completing and returning the response form accompanying the device recall letter. Customers with questions regarding the notice were instructed to contact the Customer Support Center: electronically at http://www.beckmancoulter.com/customersupport/support or via phone at 1-800-854-3633, in the United States and Canada. Customers with questions located outside the United States and Canada, were instructed to contact local Beckman Coulter representatives.
• Quantity in Commerce: 4350 total units (1713 in U.S.)
• Distribution: United States: nationwide, including Puerto Rico; and Foreign: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Bermuda, Bolivia, Brazil, Brunei Darussalam, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kenya, Korea, Kuwait, Lebanon, Lithuania, Macao, Macedonia, Malaysia, Maldives, Martinique, Mexico, Moldova, Republic Of, Montenegro, Morocco, Netherlands, New Zealand, Nigeria, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, U.A.E, Uganda, United Kingdom, United States, Uruguay, Venezuela, Vietnam
• 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