BEUDAMED
    FDA Recall Terminated

    Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each kit is composed of an outer box, a shrink-wrapped inner box that contains the blood collection card with an unique PIN, the instructions for use and ''Frequently Asked Questions'', a polybag component that includes two lancets, one gauze pad, one adhesive bandage and one alcohol prep pad, a specimen return envelope and a prepaid return mailer either designated as U.S. first class or FedEx; Home Access Health Corporation, Hoffman Estates, IL 60195-5200; UPC 0 83170 51000 5

    Recall: Z-0150-2007 · Initiated October 6, 2006

    Recall

    Recall Number
    Z-0150-2007
    Event Number
    36429
    Firm
    Home Access Health Corp (HAHC)
    FEI Number
    3000206414
    Product Code
    MZO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 6, 2006
    Posted
    November 4, 2006
    Terminated
    May 31, 2007
    Address
    2401 Hassell Rd, Ste 1510, Hoffman Estates, IL, 60195-5241

    Description

    Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each kit is composed of an outer box, a shrink-wrapped inner box that contains the blood collection card with an unique PIN, the instructions for use and ''Frequently Asked Questions'', a polybag component that includes two lancets, one gauze pad, one adhesive bandage and one alcohol prep pad, a specimen return envelope and a prepaid return mailer either designated as U.S. first class or FedEx; Home Access Health Corporation, Hoffman Estates, IL 60195-5200; UPC 0 83170 51000 5

    Reason

    Wrong Expiration Date; The kits were labeled with Expiration/Use By dates; that exceed the expiration dates of the sterile safety lancet component of the kit.

    Action

    Recall letters dated 10/6/06 were sent to the direct accounts via FedEx on the same date. The accounts were informed of incorrect Use By dates on the kits based on the lancet component of the kit, and that the lancet may not be sterile as of the printed Use By date on the kit. The letters listed the specific products and affected lot numbers shipped to the individual account, and requested them to examine their inventory for the affected product and return it via UPS to Home Access for replacement. No test results will be provided to any customer who uses the affected product after 10/31/06. Any questions were directed to 1-800-871-6046.

    Distribution

    Nationwide

    Quantity

    13,911 kits