BEUDAMED
    FDA Recall Terminated

    ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)

    Recall: Z-0902-2015 · Initiated November 13, 2014

    Recall

    Recall Number
    Z-0902-2015
    Event Number
    69773
    Firm
    Horiba Instruments, Inc dba Horiba Medical
    FEI Number
    3002698356
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    November 13, 2014
    Posted
    January 2, 2015
    Terminated
    March 19, 2015
    Address
    34 Bunsen, Irvine, CA, 92618-4210

    Description

    ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)

    Reason

    HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm. The defect would result in a false high or false low results for HbA1c and false high results for magnes

    Action

    A recall letter was sent on 11/13/14 to all customers who purchased the ABX PENTRA 400 Clinical Chemistry Analyzer. The letter informs the customer of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact their local HORIBA Medical representative.

    Distribution

    Nationwide in US

    Quantity

    443 units