BEUDAMED
    FDA Recall Open, Classified

    Atellica 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): 11097597

    Recall: Z-0722-2021 · Initiated November 23, 2020

    Recall

    Recall Number
    Z-0722-2021
    Event Number
    86900
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JQA
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    November 23, 2020
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    Atellica 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): 11097597

    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.

    Action

    Siemens Healthcare Diagnostics Urgent Field Safety Notice letter beginning November 23, 2020 via Fed Ex and outside the US the distribution is determined at the country level. Letter states reason for recall , health risk and action to take: For the product listed above, please perform the following steps: 1. Review and apply the preliminary precision performance characteristics of d8% CV at a GGT concentration of approximately 27 U/L 42 U/L provided. 2. Please review this letter with your Medical Director. 3. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 4. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Contact your Siemens Customer Care Center or your local Siemens technical support representative. The precision section of the IFUs will be updated when the investigation is complete. The updated IFUs will be uploaded into Document Library where all registered users who opt in to receive alerts will be notified of the updated IFU.

    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

    731 units US; 16824 units OUS