BEUDAMED
    FDA Recall Terminated

    Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.

    Recall: Z-0964-2012 · Initiated November 16, 2010

    Recall

    Recall Number
    Z-0964-2012
    Event Number
    60391
    Firm
    Alere San Diego
    FEI Number
    1000125596
    Product Code
    CHH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 16, 2010
    Posted
    February 6, 2012
    Terminated
    August 22, 2013
    Address
    9975 Summers Ridge Rd, San Diego, CA, 92121-2997

    Description

    Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.

    Reason

    Alere has identified that a bias on results for certain analytes tested on the Alere Cholestech LDX System may exist due to humidity variability.

    Action

    Alere sent an Updated Urgent Recall Notification Letter in March 2012 to all their customers who are in possession of one or more Cholestech LDX Systems. The updated letter provides the customers with important information about the problem identified and the actions to be taken. Customers are instructed to operate their device in a controlled environment that maintains humidity within 40-60% relative humidity if the device has not been upgraded with ROM pack v3.40. If humidity cannot be monitored, the device is no longer CLIA waived. Customers are instructed to complete the customer verification form. A previous notice from Alere sent in November 2010 instructs users to contact Alere to receive the ROM pack upgrade. Customers may email [email protected] to request an electronic form to complete and return via email. Customers can expect their ROM packs approximately 10 to 14 business days after Alere receives their request. If customers have transferred ownership to another party, they can email Alere at [email protected] with the updated contact information. If customers are not currently using their Cholestech LDX System, it is recommended that the ROM Pack upgrade be installed prior to restarting use of any Cholestech LDX analyzer. Customers with questions regarding this communication can call Alere at (877) 441-7440, option 1 or email at [email protected].

    Distribution

    Worldwide distribution including USA

    Quantity

    22,000 meters