BEUDAMED
    FDA Recall Terminated

    Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.

    Recall: Z-0408-2017 · Initiated October 24, 2016

    Recall

    Recall Number
    Z-0408-2017
    Event Number
    75526
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JJX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 24, 2016
    Terminated
    February 1, 2018
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.

    Reason

    Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.

    Action

    Beckman Coulter sent an Urgent Medical Device Recall letter dated October 24, 2016 was sent to all their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions regarding the notice are instructed to contact Customer Technical Support Center at http://www.beckmancoulter.com, (800) 854-3633 in US and Canada, and to contact local Beckman Coulter representative if outside of US and Canada.

    Distribution

    US Nationwide Distribution in the states of: UT, MI, MA, LA, IN, NC, CA, TX, NJ, IL, WI, MN, FL, KA, NY, CO, WA, KY, VA, and AL. Affected geographies: Belgium, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Mexico, Philippines, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan.

    Quantity

    625 kits total (113 kits in US)