BEUDAMED
    FDA Enforcement Class II Terminated

    ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.

    Recall: Z-0632-2013 · Reported January 9, 2013

    Enforcement

    Recall Number
    Z-0632-2013
    Event ID
    63838
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Horiba Instruments, Inc dba Horiba Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 9, 2013
    Initiation Date
    October 10, 2012
    Classification Date
    January 3, 2013
    Termination Date
    September 12, 2013
    Address
    34 Bunsen, N/A, Irvine, CA, 92618-4210, United States

    Description

    ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.

    Reason

    Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.

    Code Info

    Lot number: 00456-4108

    Distribution

    Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.

    Quantity

    66886 units