BEUDAMED
    FDA Recall Terminated

    Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access Ostase Assay is used for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Pagets disease.

    Recall: Z-1240-2012 · Initiated November 10, 2011

    Recall

    Recall Number
    Z-1240-2012
    Event Number
    61214
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    CIN
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 10, 2011
    Posted
    March 21, 2012
    Terminated
    June 26, 2012
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access Ostase Assay is used for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Pagets disease.

    Reason

    The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access Ostase Calibrator and QC lots that contain the implicated raw material.

    Action

    Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 9, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard all remaining inventory. In addition, a Response Form was enclosed for customers to complete and return. Contact Beckman's Customer Support Center at (800) 854-3633 for questions regarding this notice.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong, Hungary, India,Ireland, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, Netherlands, New Zealand, Panama, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.

    Quantity

    8228 units total (1193 units in US)