BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997

    Recall: Z-1790-2020 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1790-2020
    Event ID
    85282
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CSL Behring GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 29, 2020
    Initiation Date
    March 2, 2020
    Classification Date
    April 23, 2020
    Termination Date
    October 5, 2020
    Address
    Emil-Von-Behring-Str. 76, N/A, Marburg, N/A, N/A, Germany

    Description

    Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997

    Reason

    Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring

    Code Info

    US Lot number: 49822 UDI: 842768018534 OUS: Lot numbers: 49729, 49849, 49985, 50084 Exp. Date: 2020-04-11

    Distribution

    IN, KS, MO, OH, VA Foreign: Australia, Austria, Bangladesh, Belgium, Canada, China Czech Republic, Egypt, Finland, France, Germany, Great Britain, Hungary India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Republic Korea, Russia Federation, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Taiwan

    Quantity

    297 PCK US; 1247 PCK OUS