BEUDAMED
    FDA Recall Terminated

    Siemens CLINITEST hCG -Pregnancy Test (qualitative), Radio immunoassay,Human Chorionic Gonadotropin (hCG) test system. Package of 25. Product Code 1760/ Catalog# 06484105). For in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens.

    Recall: Z-0972-2012 · Initiated December 15, 2011

    Recall

    Recall Number
    Z-0972-2012
    Event Number
    60662
    Firm
    Siemens Healthcare Diagnostics
    FEI Number
    2432235
    Product Code
    JHI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 15, 2011
    Posted
    February 7, 2012
    Terminated
    March 30, 2015
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    Siemens CLINITEST hCG -Pregnancy Test (qualitative), Radio immunoassay,Human Chorionic Gonadotropin (hCG) test system. Package of 25. Product Code 1760/ Catalog# 06484105). For in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens.

    Reason

    A potential for false positive or increase in borderline results with patients and commercially available negative control material.

    Action

    Siemens issued Overnight Mailings of Urgent: Recall Notices on December 15, 2011 for delivery beginning December 16, 2011 to Distributors and end users. Customer bulletin has been issued instructing customers to discontinue use of product and discard impacted inventory. Customers are to contact their distributor regarding credit for unused product. For technical questions contact Siemens Technical Solutions Center at 877-229-3711.

    Distribution

    Worldwide Distribution -- US, Austria, Germany, Great Britain, Denmark, Norway, Sweden, Poland, Netherlands, Luxembourg, Belgium, Finland, France, Greece, Ireland, Italy, Portugal, Qatar, Saudi Arabia, Slovakia, Slovenia, and Switzerland.

    Quantity

    48,578 Kits (25 tests / kit)