BEUDAMED
    FDA Recall Terminated

    Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760

    Recall: Z-1475-2008 · Initiated October 17, 2007

    Recall

    Recall Number
    Z-1475-2008
    Event Number
    47352
    Firm
    Siemens Medical Solutions Diagnostics
    FEI Number
    3002637618
    Product Code
    JHI
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 17, 2007
    Posted
    September 1, 2008
    Terminated
    March 15, 2012
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637

    Description

    Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760

    Reason

    False positive hCG results

    Action

    Siemens issued a Service Bulletin to Siemens Healthcare Diagnostics Branches via email on 10/17/007, and a customer bulletin to outside the US . Users are requested to discontinue use and discard the product. A Completion Notification was requested to be completed and returned by the faculties.

    Distribution

    Nationwide Canada, France, Korea, Netherlands, UK

    Quantity

    3065 kits