BEUDAMED
    FDA Recall Terminated

    Alcohol Control sold by Pointe Scientific; Catalog # 7-A7504-CTL.

    Recall: Z-1546-06 · Initiated June 9, 2006

    Recall

    Recall Number
    Z-1546-06
    Event Number
    35499
    Firm
    Pointe Scientific, Inc.
    FEI Number
    1827821
    Product Code
    JIX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 9, 2006
    Posted
    September 30, 2006
    Terminated
    November 20, 2007
    Address
    5449 Research Dr, Canton, MI, 48188-2261

    Description

    Alcohol Control sold by Pointe Scientific; Catalog # 7-A7504-CTL.

    Reason

    Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.

    Action

    Consignees were notified via recall letter dated 6/9/06 and a second letter dated 6/21/06 extending the recall to additional products/lots, to cease using the products, conduct a recall to the user level, destroy products on hand and to notify the firm via the response form of the amount destroyed for replacement purposes.

    Distribution

    Worldwide distribution ---- including USA and countries of Canada, Ecuador, Germany, Greece, India, Mexico, Peru, Poland, Portugal, Trinidad, United Arab Emirates and United Kingdom.

    Quantity

    44 units