BEUDAMED
    FDA Recall 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 · Initiated April 26, 2016

    Recall

    Recall Number
    Z-1923-2016
    Event Number
    74002
    Firm
    Greiner Bio-One North America, Inc.
    FEI Number
    3001451379
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 26, 2016
    Terminated
    August 22, 2016
    Address
    4238 Capital Dr, Monroe, NC, 28110-7681

    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.

    Action

    Greiner Bio-One North America, Inc. sent an Urgent Product Recall letter dated April 26, 2016, to all affected consignees. The letter requested that they stop distribution of the product and to provide Greiner with a list of their sub-accounts. The letter included a Product Disposition/Site Confirmation form which is to be returned to Greiner Bio-one. Consignees with questions were instructed to call 800-515-8112. For questions regarding this recall call 704-261-7823.

    Distribution

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

    Quantity

    250,800 pieces (209 cases)