BEUDAMED
    FDA Recall Terminated

    ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)

    Recall: Z-1486-2018 · Initiated February 21, 2018

    Recall

    Recall Number
    Z-1486-2018
    Event Number
    79678
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    LTK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 21, 2018
    Terminated
    May 16, 2019
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)

    Reason

    Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.

    Action

    A Customer Notification was sent to customers on 2/21/18. The letter instructs customers to refer to the information provided until the appropriate updates are available in the assay instructions for use. The letter is to be retained and forwarded to those who may have received the product.

    Distribution

    US Nationwide, and the following countries: Albania, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Mexico, Morocco, Myamar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan,Thailand, Turkey, United Arab Emirates, Ukraine, United Kingdom, Uruguay, Uzbekistan,Vatican City, and Vietnam.

    Quantity

    SMN 10310443 (1-pack/100 tests) - 13257 kits; SMN 10315696 (5-pack/500 tests) - 9930 kits