BEUDAMED
    FDA Recall Terminated

    Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001.

    Recall: Z-0100-06 · Initiated March 28, 2005

    Recall

    Recall Number
    Z-0100-06
    Event Number
    31372
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 28, 2005
    Posted
    October 28, 2005
    Terminated
    April 6, 2006
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001.

    Reason

    Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.

    Action

    Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions.

    Distribution

    Nationwide.

    Quantity

    unknown.