BEUDAMED
    FDA Recall Terminated

    CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).

    Recall: Z-0737-2007 · Initiated February 28, 2007

    Recall

    Recall Number
    Z-0737-2007
    Event Number
    37602
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 28, 2007
    Posted
    April 11, 2007
    Terminated
    June 13, 2007
    Address
    9115 Hague Rd, Indianapolis, IN, 46250-0416

    Description

    CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).

    Reason

    The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.

    Action

    All consignees were notified by telephone on/or about 2/28/07 and some received a follow-up letter dated 3/2/07 or 3/5/07.

    Distribution

    Nationwide-California, Georgia, Louisiana, Maryland, Oklahoma and Texas.

    Quantity

    10