BEUDAMED
    FDA Recall Terminated

    Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following Cup and Dip product models involved in the recall: 40900 40901 30500-A 30575 -A 30603-A 30671-A 30800-A 30802-3A 30900-A 30950-A 31102-A 40901C 60410-3A 60500-A 60505-A 60524-A 60526-A 60535-A 60600-A 60602-4A 60630-A 60635-4A 60640-4A 60705-4A 60709-A 60800-6A 60800-A 60801-A 60820-A 60903-A 60910-A 60921-A 60925-A 60930-A 61020-A 61023-A 61026-4A 61028-3A 61030-3A 61044-6A 61052-4A 61100-A 61204-A 61206-4A 61206-6A 61303-A 61401-A 61404-A 65500-4A 70410-4A 70500-3A 70500-A 70550-A 70602-3A 70604-6A 70630-3A 70640-4A 70808-6A 70910-A In Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine.

    Recall: Z-3104-2011 · Initiated November 1, 2010

    Recall

    Recall Number
    Z-3104-2011
    Event Number
    59567
    Firm
    Express Diagnostics Int'l., Inc.
    FEI Number
    3014946040
    Product Code
    DIC
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    November 1, 2010
    Posted
    August 31, 2011
    Terminated
    July 6, 2012
    Address
    1550 Industrial Dr, Blue Earth, MN, 56013-1100

    Description

    Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following Cup and Dip product models involved in the recall: 40900 40901 30500-A 30575 -A 30603-A 30671-A 30800-A 30802-3A 30900-A 30950-A 31102-A 40901C 60410-3A 60500-A 60505-A 60524-A 60526-A 60535-A 60600-A 60602-4A 60630-A 60635-4A 60640-4A 60705-4A 60709-A 60800-6A 60800-A 60801-A 60820-A 60903-A 60910-A 60921-A 60925-A 60930-A 61020-A 61023-A 61026-4A 61028-3A 61030-3A 61044-6A 61052-4A 61100-A 61204-A 61206-4A 61206-6A 61303-A 61401-A 61404-A 65500-4A 70410-4A 70500-3A 70500-A 70550-A 70602-3A 70604-6A 70630-3A 70640-4A 70808-6A 70910-A In Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine.

    Reason

    Express Diagnostics Intl'l Inc is recalling DrugCheck devices because they were informed via letter from the alcohol test strip manufacturer on October 27, 2010 that the product was not 510 K cleared for in vitro diagnostic use and could not be labeled as such in the US.

    Action

    Express Diagnostics Intl., Inc. sent an Updated Recall Notice dated November 1, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed if they have open orders of the affected product to contact customer service about their order. Customers were asked to complete and fax the form on page 3 of the document to 507-526-2252. Further shipment of products could not continue until Express Diagnostics received the signed form. For questions regarding this recall call 507-526-3951.

    Distribution

    Nationwide Distribution including AZ, CA,K CT, FL, GA, IL, IA, LA, MD, MA, MN, MS, MO,K MT, NE, NJ, NY, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY.

    Quantity

    56,650