BEUDAMED
    FDA Recall Terminated

    Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321.

    Recall: Z-1350-2008 · Initiated December 26, 2007

    Recall

    Recall Number
    Z-1350-2008
    Event Number
    46214
    Firm
    Wescor, Inc
    FEI Number
    1717966
    Product Code
    JJM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 26, 2007
    Posted
    March 27, 2008
    Terminated
    March 27, 2008
    Address
    459 South Main Street, Logan, UT, 84321-5207

    Description

    Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321.

    Reason

    Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.

    Action

    Consignees were notified by Recall Notification letter on 01/11/2008, and asked to arrange for return of affected product.

    Distribution

    Worldwide- USA, Argentina, Australia, Brazil, Canada, Denmark, England, France, Germany, Greece, Hungary, Japan, Malaysia, Mexico, The Netherlands, New Zealand, Paraguay, Poland, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and The United Kingdom.

    Quantity

    950 vials