BEUDAMED
    FDA Recall Terminated

    NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-000

    Recall: Z-0222-2007 · Initiated September 29, 2006

    Recall

    Recall Number
    Z-0222-2007
    Event Number
    36699
    Firm
    Inverness Medical Professional Diagnostics
    FEI Number
    1221359
    Product Code
    MJH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2006
    Posted
    November 29, 2006
    Terminated
    March 13, 2007
    Address
    10 Southgate Rd, Scarborough, ME, 04074-8303

    Description

    NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-000

    Reason

    Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches

    Action

    Binax Inc. DBA Inverness Medical notified consignees by letter on 09/29/06 advising users to return unused product and distributors to recall to the user level.

    Distribution

    Worldwide, including USA, Canada, EU, South Korea, Singapore

    Quantity

    531 kits