BEUDAMED
    FDA Recall Terminated

    OLA 2500 Olympus Lab Automation Systems to include the following models (all serial numbers): S2 Full Size, S3 Full Size, Standard Full Size and High Speed Full Size (Aliquoter) manufactured by Olympus Life and Material Science Europa GmbH, Germany and distributed by Olympus America, Inc., 3131 W. Royal Ln., Irving, TX 75063.

    Recall: Z-0322-06 · Initiated November 18, 2005

    Recall

    Recall Number
    Z-0322-06
    Event Number
    34058
    Firm
    Olympus America, Inc
    FEI Number
    3002406108
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 18, 2005
    Posted
    December 23, 2005
    Terminated
    March 10, 2008
    Address
    3131 W Royal Ln, Irving, TX, 75063-3104

    Description

    OLA 2500 Olympus Lab Automation Systems to include the following models (all serial numbers): S2 Full Size, S3 Full Size, Standard Full Size and High Speed Full Size (Aliquoter) manufactured by Olympus Life and Material Science Europa GmbH, Germany and distributed by Olympus America, Inc., 3131 W. Royal Ln., Irving, TX 75063.

    Reason

    Lab Automation System may dilute samples with water.

    Action

    Firm initiated recall on 11/18/05 via letter to all direct accounts.

    Distribution

    Nationwide; Distribution was made to laboratories and blood centers located in CA, CO, GA, NC, and OH.

    Quantity

    6 total units.