BEUDAMED
    FDA Recall Terminated

    iChem VELOCITY Urine Chemistry Analyzer

    Recall: Z-0843-2020 · Initiated November 7, 2019

    Recall

    Recall Number
    Z-0843-2020
    Event Number
    84268
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    KQO
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    November 7, 2019
    Terminated
    September 11, 2023
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    iChem VELOCITY Urine Chemistry Analyzer

    Reason

    Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may result in erroneous Specific Gravity (SG) results.

    Action

    The firm, Beckman Coulter, sent an "URGENT MEDICAL DEVICE RECALL" letters on 11/07/2019. The letter explained the problem and how to recognize if the S3 flag has been disabled in the instrument. The letter further instructs the following: - Review results to determine if samples report an SG result of >1.060 or an SG result of S3 - If the SG result is >1.060 or S3, test samples for SG using an alternate method* determined by your laboratory - If persistent SG results are >1.060 or persistent S3 results are seen, contact your local Beckman Coulter Representative If you have any questions regarding this notice, please contact Beckman Coulter Customer Support Center: Via our website: http://www.beckmancoulter.com Support > Request Instrument Support. By phone: call 800-526-7694 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter Representative.

    Distribution

    Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, France, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Macau, Malaysia, Maldives, Mexico, Moldova, Montenegro, Morocco, Netherlands, Netherlands Antillean, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam.

    Quantity

    4314 units