BEUDAMED
    FDA Enforcement Class II Terminated

    ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA¿ Chemistry Systems. Copies of IFUs included in submission.

    Recall: Z-2299-2016 · Reported August 3, 2016

    Enforcement

    Recall Number
    Z-2299-2016
    Event ID
    74524
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 3, 2016
    Initiation Date
    June 17, 2016
    Classification Date
    July 28, 2016
    Termination Date
    March 15, 2017
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA¿ Chemistry Systems. Copies of IFUs included in submission.

    Reason

    Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (THEO_2) reagent lot 334018, may exhibit increased imprecision for commercially available Bio-Rad Liquichek TDM Quality Control Levels and patient samples

    Code Info

    ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent - SMN# 10377503, Lot # 334018

    Distribution

    Distributed to: CA, CT, DE, FL, GA, IA, IN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, TN, VA, WA

    Quantity

    658 units