BEUDAMED
    FDA Recall Terminated

    iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips

    Recall: Z-1384-2017 · Initiated January 30, 2017

    Recall

    Recall Number
    Z-1384-2017
    Event Number
    76374
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    KQO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 30, 2017
    Posted
    March 1, 2017
    Terminated
    August 19, 2017
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips

    Reason

    The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.

    Action

    Beckman Coulter/Iris sent an Urgent Medical Device Recall letter dated January 30, 2017 to all affected customers to inform them that Iris International has determined that sample probe misalignment or bending on the iChemVELOCITY may lead to a remote possibility of false negative results due to inadequate strip dosing. Customers were informed that Inadequate dosing may lead to incorrect patient results which may not be detected by quality control, or to a delay in reporting results. Incorrect patient results might be observed as an unexpected discrepancy between instrument results and the patient's clinical picture. The greatest impact could occur when proteinuria is not detected. Customers were instructed to complete and return the enclosed Response Form within 10 days. Customers with questions were instructed to contact their local support representative: Via our website, at http://www.beckmancoulter.com By phone, call 800 854-3633 in the United States and Canada

    Distribution

    Worldwide Distribution - US (nationwide) and internationally to Argentina, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Canada, Chile, China, Columbia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Macau, Malaysia, Mexico, Moldova, Montenegro, Netherlands, New Zealand, Nigeria, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Republic and Venezuela.

    Quantity

    3175 units total (1697 units in US)