BEUDAMED
    FDA Recall Terminated

    Uritek TC-101Urine Analyzer, catalog number TC-101

    Recall: Z-0472-06 · Initiated December 22, 2005

    Recall

    Recall Number
    Z-0472-06
    Event Number
    34304
    Firm
    Teco Diagnostics
    FEI Number
    1832216
    Product Code
    KQO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 22, 2005
    Posted
    February 4, 2006
    Terminated
    March 7, 2012
    Address
    1268 N Lakeview Ave, Anaheim, CA, 92807-1831

    Description

    Uritek TC-101Urine Analyzer, catalog number TC-101

    Reason

    When reading the Nitrite parameter on the Teco Diagnostics URS-10 strips, some positive nitrite samples may be read by the machine as negative.

    Action

    On December 22nd,2005 the firm sent the notification letter along with a replacement unit of TC-101. These letters and replacement units were send via Fed ex ground and the tracking numbers and serial numbers of the sent units are also noted. Also noted are the return authorization numbers assigned to each respective customer.

    Distribution

    Nationwide

    Quantity

    50