BEUDAMED
    FDA Enforcement Class II Ongoing

    ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)

    Recall: Z-0721-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0721-2021
    Event ID
    86900
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2020
    Initiation Date
    November 23, 2020
    Classification Date
    December 23, 2020
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)

    Reason

    Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.

    Code Info

    All lot codes. UDI: 10309495 (20 mL) = 00630414508344 10316298 (70 mL) = 00630414209753

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Australia, Austria, Bahamas, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, Uruguay, Vatican City, Vietnam. ¿¿¿¿ ¿¿¿¿¿

    Quantity

    397 units US; 1713 units OUS