BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-1366-2018 · Initiated November 10, 2017

    Recall

    Recall Number
    Z-1366-2018
    Event Number
    79368
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    KQO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 10, 2017
    Terminated
    December 21, 2022
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    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

    Reason

    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.

    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.

    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

    Quantity

    4350 total units (1713 in U.S.)