BEUDAMED
    FDA Recall Terminated

    ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the labeling, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. Each control level is provided in one vial of 10 ml. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

    Recall: Z-0924-2014 · Initiated December 18, 2013

    Recall

    Recall Number
    Z-0924-2014
    Event Number
    67133
    Firm
    Horiba Instruments, Inc dba Horiba Medical
    FEI Number
    3002698356
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    December 18, 2013
    Posted
    February 3, 2014
    Terminated
    October 9, 2014
    Address
    34 Bunsen, Irvine, CA, 92618-4210

    Description

    ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the labeling, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. Each control level is provided in one vial of 10 ml. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

    Reason

    HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX PENTRA Chemistry Analyzers that the Target Range for Creatinine has been updated. The ABX PENTRA Urine Control L/H lot specific annexes have been updated to include revised acceptable Target Ranges for Creatinine.No other analyte values are affected.

    Action

    HORIBA Medical sent an Urgent Safety Notice dated December 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to update their Quality Control procedures to include the new Creatinine Target Ranges for the ABX PENTRA Urine Control L/H Reference #: A11A01674 and Lot #s: 1207001, 1303601, and 1300701. Customers were instructed to complete and return the enclosed response form to verify their understanding of the Field Safety Notice. Customers with questions were instructed to contact their local HORIBA Medical representative. For questions regarding this recall call 949-453-0500.

    Distribution

    Worldwide Distribution - USA (nationwide) and Canada.

    Quantity

    531