BEUDAMED
    FDA Recall Terminated

    iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.

    Recall: Z-2441-2015 · Initiated July 15, 2015

    Recall

    Recall Number
    Z-2441-2015
    Event Number
    71780
    Firm
    Iris Diagnostics
    FEI Number
    2023446
    Product Code
    KQO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 15, 2015
    Posted
    August 21, 2015
    Terminated
    May 26, 2016
    Address
    9172 Eton Ave, Chatsworth, CA, 91311-5805

    Description

    iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.

    Reason

    Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling.

    Action

    An Urgent Medical Device Recall letter dated 7/15/15 was sent to all customers who purchased the iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips REF 800-7212 and 800-7212-001. As a result of internal investigations following customer complaints, Iris International has determined that the iChemVELOCITY systems do not maintain the on-board strip stability claim of 5 days at 18-28C at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions or concerns regarding the recall notice, are instructed to contact Beckman Coulter Customer Support at http://www.beckmancoulter.com or call (800) 526-7694 in US and Canada.

    Distribution

    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Jordan, Republic of Korea, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

    Quantity

    2,448 units