BEUDAMED
    FDA Enforcement Class II Terminated

    4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate

    Recall: Z-1923-2016 · Reported June 15, 2016

    Enforcement

    Recall Number
    Z-1923-2016
    Event ID
    74002
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Greiner Bio-One North America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2016
    Initiation Date
    April 26, 2016
    Classification Date
    June 7, 2016
    Termination Date
    August 22, 2016
    Address
    4238 Capital Dr, N/A, Monroe, NC, 28110-7681, United States

    Description

    4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate

    Reason

    The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.

    Code Info

    Lot A151137L

    Distribution

    Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico

    Quantity

    250,800 pieces (209 cases)