BEUDAMED
    FDA Recall Terminated

    Roche brand AccuData GTS Plus System; Catalog number 3000249, material number 03000249001.

    Recall: Z-0881-05 · Initiated April 18, 2005

    Recall

    Recall Number
    Z-0881-05
    Event Number
    31619
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 18, 2005
    Posted
    June 11, 2005
    Terminated
    March 7, 2006
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche brand AccuData GTS Plus System; Catalog number 3000249, material number 03000249001.

    Reason

    If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.

    Action

    Consignees were notified via letter dated 4/18/05, which included instructions on how to inspect their unit for damage, and how to prevent future damage.

    Distribution

    Nationwide and Guam.