BEUDAMED
    FDA Recall Terminated

    ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2

    Recall: Z-0645-2013 · Initiated September 20, 2012

    Recall

    Recall Number
    Z-0645-2013
    Event Number
    63829
    Firm
    Horiba Instruments, Inc dba Horiba Medical
    FEI Number
    3002698356
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 20, 2012
    Posted
    January 7, 2013
    Terminated
    March 12, 2013
    Address
    34 Bunsen, Irvine, CA, 92618-4210

    Description

    ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2

    Reason

    Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software

    Action

    .A recall letter dated 11/09/2012 was sent to all their customers who received the ABX PENTRA ML products. The letter informed the customers of the problem identified and the action to be taken. Customers are instructed to complete and return the enclose response form within 10 days. Customers with questions about the letter are instructed to contact their local HORIBA Medical representative. Recall Letter, as produced per FCD-0377, Field Safety Notice & Acknowledgement will be mailed via FedEx to the ten (10) customers noted on the list the week of November 12, 2012. Effectivity will be evaluated by receipt of the Field Safety Notice Acknowledgment Form. Follow-up communications with customers will be conducted, as needed.

    Distribution

    Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.

    Quantity

    10 units