BEUDAMED
    FDA Recall Terminated

    IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.

    Recall: Z-0884-05 · Initiated April 29, 2005

    Recall

    Recall Number
    Z-0884-05
    Event Number
    32036
    Firm
    International Remote Imaging Systems Inc
    FEI Number
    2023446
    Product Code
    JJW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 29, 2005
    Posted
    June 11, 2005
    Terminated
    May 7, 2012
    Address
    9172 Eton Ave, Chatsworth, CA, 91311-5805

    Description

    IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.

    Reason

    Nonconformance to performance specifications.

    Action

    Firm telephoned customers April 29, 2005 requesting return of product. All customers were contacted as of May 4, 2005.

    Distribution

    Nationwide.

    Quantity

    107