BEUDAMED
    FDA Recall Terminated

    Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).

    Recall: Z-1139-2013 · Initiated March 6, 2013

    Recall

    Recall Number
    Z-1139-2013
    Event Number
    64671
    Firm
    Alere San Diego, Inc.
    FEI Number
    1000125596
    Product Code
    CKD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 6, 2013
    Posted
    April 17, 2013
    Terminated
    August 13, 2013
    Address
    9975 Summers Ridge Rd, San Diego, CA, 92121-2997

    Description

    Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).

    Reason

    The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System.

    Action

    Alere sent an "URGENT MEDICAL DEVICE RECALL UPDATE" letter dated March 6, 2013 to all affected customers. The letter informed the customers of the problem identified and the actions to be taken. Customers with any questions about the recall notification, are instructed to contact Alere San Diego 9975 Summers Ridge Rd, San Diego, CA 92121; (877) 308-8289; Fax: (858) 805-8457. Customers are instructed to complete the customer response form even if they do not have any involved product.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, South Africa, Netherlands, Italy, Brazil, Singapore, Russia, Hong Kong, Argentina, South Korea, Philippines, El Salvador, Indonesia, and Trinidad.

    Quantity

    38,571 kits